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ICHOM Coronary Artery Disease - Peri-Inverventional Clinical Form

- 30.04.20 - 1 Formulário, 8 Grupos de itens, 46 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Demographic factors, Baseline health status, Prior Treatments, TREATMENT VARIABLES, Acute complications of treatment, Major surgery complications, Major interventional cardiology complications
CORONARY ARTERY DISEASE DATA COLLECTION Version 2.0.3 Revised: April 5th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Asymptomatic Coronary Artery Disease | Stable Angina | Acute Coronary Syndrome (Includes AMI) Treatment Approaches: Lifestyle Modification | Drug Therapy | Percutaneous Coronary Intervention (PCI) | Coronary Artery Bypass Grafting (CABG) This form contains peri-interventional clinical items. The items cover a timespan from prior to the intervention (e.g. PCI or CABG) until 30 days after it. They should be assessed at the entry event and at any new index event (e.g. new revascularization procedure or new diagnosis of ACS). Questionnaires used in this standard set: Rose Dyspnea Scale: The Rose Dyspnea Scale is free for all health care organizations, and a license is not needed. More information may be found at http://www.ahjonline.com/article/S0002-8703(09)00266-X/abstract Patient Health Questionnaire (PHQ-2): The PHQ-2 is free for all health care organizations, and a license is not needed. Copyright Pfizer, more Information on http://www.phqscreeners.com/ Seattle Angina Questionnaire (SAQ-7): Due to the need for a license for use of the SAQ-7 the actual questions of SAQ-7 will not be part of this version of the standard set. Publication: McNamara RL, Spatz ES, Kelley TA, et al. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015;4(5):e001767. Published 2015 May 19. doi:10.1161/JAHA.115.001767 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

dbGaP phs000917 MIGen_ExS: PROMIS - pht004738.v1.p1

- 14.04.24 - 5 Formulários, 1 Grupo de itens, 3 Elementos de dados, 1 Idioma
Grupo de itens: pht004738
Principal Investigator: Stacey Gabriel, PhD, Broad Institute, Boston, MA, USA MeSH: Coronary Artery Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000917 The Pakistan Risk of Myocardial Infarction (PROMIS) study is a retrospective multicenter case-control cohort study of individuals with and without coronary heart disease from Pakistan. Multiple biological samples have been collected from the participants including DNA, plasma, serum, and whole blood. The goal of the study is to recruit 20,000 cases and 20,000 controls of Pakistani descent. All exome sequencing was performed at the Broad Institute of Harvard and MIT; samples sequence capture was performed using either Agilent's SureSelect Human All Exon Kit v2 or Illumina's ICE capture reagent; and sequencing was performed on an Illumina HiSeq 2000 or 2500.

pht004739.v1.p1

1 Grupo de itens 3 Elementos de dados

pht004741.v1.p1

1 Grupo de itens 2 Elementos de dados

Eligibility

1 Grupo de itens 1 Elemento de dados

pht004740.v1.p1

1 Grupo de itens 2 Elementos de dados

dbGaP phs000916 MIGen_ExS: Munich-MI - Eligibility

- 14.04.24 - 5 Formulários, 1 Grupo de itens, 1 Elemento de dados, 1 Idioma
Grupo de itens: IG.elig
Principal Investigator: Stacey Gabriel, PhD, Broad Institute, Boston, MA, USA MeSH: Coronary Artery Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000916 The Munich-MI study is a case-control cohort study recruited at the German Heart Center in Munich, Germany. It is focused on understanding the genetic contributors to early myocardial-infarction (MI) in the German population. All exome sequencing was performed at the Broad Institute of Harvard and MIT; samples sequence capture was performed using Illumina's ICE Capture reagent and sequencing was performed on an Illumina HiSeq 2000 or 2500.

pht004734.v1.p1

1 Grupo de itens 3 Elementos de dados

pht004735.v1.p1

1 Grupo de itens 3 Elementos de dados

pht004736.v1.p1

1 Grupo de itens 2 Elementos de dados

pht004737.v1.p1

1 Grupo de itens 2 Elementos de dados

dbGaP phs000902 MIGen_ExS: Regicor - Eligibility

- 06.04.24 - 5 Formulários, 1 Grupo de itens, 1 Elemento de dados, 1 Idioma
Grupo de itens: IG.elig
Principal Investigator: Stacey Gabriel, PhD, Broad Institute, Boston, MA, USA MeSH: Coronary Artery Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000902 The Registre Gironi del Cor (REGICOR) study developed a nested case-control cohort from the Girona province in Spain in order to study genetic factors associated with the development of coronary heart disease. All exome sequencing was performed at the Broad Institute of Harvard and MIT; samples sequence capture was performed using Agilent SureSelect Human All Exon Kit v2 and sequencing was performed on an Illumina HiSeq 2000 or 2500.

pht004668.v1.p1

1 Grupo de itens 3 Elementos de dados

pht004669.v1.p1

1 Grupo de itens 3 Elementos de dados

pht004670.v1.p1

1 Grupo de itens 2 Elementos de dados

pht004671.v1.p1

1 Grupo de itens 2 Elementos de dados

dbGaP phs000883 MIGen_ExS: PROCARDIS - pht004595.v1.p1

- 26.03.24 - 5 Formulários, 1 Grupo de itens, 3 Elementos de dados, 1 Idioma
Grupo de itens: pht004595
Principal Investigator: Stacey Gabriel, PhD, Broad Institute, Boston, MA, USA MeSH: Coronary Artery Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000883 The Precocious Coronary Artery Disease (PROCARDIS) study is an international, multicenter case-control study aimed at discovering the genetic contributors to premature coronary artery disease. All exome sequencing was performed at the Broad Institute of Harvard and MIT; samples sequence capture was performed using Agilent SureSelect Human All Exon Kit v2 and sequencing was performed on an Illumina HiSeq 2000 or 2500.

pht004596.v1.p1

1 Grupo de itens 3 Elementos de dados

pht004597.v1.p1

1 Grupo de itens 2 Elementos de dados

pht004598.v1.p1

1 Grupo de itens 2 Elementos de dados

Eligibility

1 Grupo de itens 1 Elemento de dados

dbGaP phs001203 Stockholm-Tartu Atherosclerosis Reverse Network Engineering Task (STARNET) - pht005966.v1.p1

- 17.05.23 - 4 Formulários, 1 Grupo de itens, 3 Elementos de dados, 1 Idioma
Grupo de itens: pht005966
Principal Investigator: Johan Björkegren, M.D., Ph.D, Department of Genetics and Genomic Sciences, The Icahn Institute for Genomics and Multiscale Biology Icahn School of Medicine at Mount Sinai, New York, NY, USA MeSH: Coronary Artery Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001203 STARNET is a genetics of RNA expression study of multiple disease-relevant tissues obtained from living patients with cardiovascular disease. Tissue samples are obtained from blood, atherosclerotic-lesion-free internal mammary artery (MAM) and atherosclerotic aortic root (AOR), subcutaneous fat (SF), visceral abdominal fat (VAF), skeletal muscle (SKLM), and liver (LIV) during open thorax surgery of 600 coronary artery disease (CAD) patients. All patients gave written informed consent. The inclusion criterion was eligibility for coronary artery by-pass graft (CABG) surgery. Patients with other severe systemic diseases, such as active systemic inflammatory disease or cancer, were excluded. The primary clinical end points were the SYNTAX score based on the extent of coronary atherosclerosis assessed from preoperative angiograms. The STARNET patients are Caucasians (31% females); 32% had diabetes, 75% had hypertension, and 67% had hyperlipidemia; and 33% had an MI before age 60. By New York Heart Association criteria, 45% were class I, 42% class II, 9% class III, and 1% class IV. TYPES AND RNA SEQUENCING: 566 DNA genotype and 3577 RNA-seq profiles from seven tissues from 600 STARNET CABG patients passed quality control (on average 511 RNA-seq profiles/tissue). DNA was genotyped with the OmniExpress Exome array (Illumina, ~900k SNPs) and imputed to a total of 14,098,063 DNA variant calls (6,245,505 with minor allele frequency 5%). The STARNET subjects mainly overlap with Caucasian of Northern European (Finnish) descent. RNA sequencing was performed using the HighSeq2000 platform, poly-A (LIV, SKLM, VAF, SF and blood) and ribo-zero (AOR, MAM) protocols with 50-100 bp read lengths, single end to 15-30 million read depth.

pht005967.v1.p1

1 Grupo de itens 4 Elementos de dados

Eligibility

1 Grupo de itens 1 Elemento de dados

pht005965.v1.p1

1 Grupo de itens 2 Elementos de dados

dbGaP phs001227 Washington University Coronary Artery Disease Study - pht005832.v1.p1

- 26.04.23 - 5 Formulários, 1 Grupo de itens, 3 Elementos de dados, 1 Idioma
Grupo de itens: pht005832
Principal Investigator: Nathan O. Stitziel, MD, PhD, McDonnell Genome Institute, Washington University School of Medicine, St. Louis, MO, USA MeSH: Coronary Artery Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001227 The genetic basis of coronary artery disease in individuals of non-European ancestry is largely unknown. The Washington University Coronary Artery Disease Study (WUCADS) recruited participants of non-European ancestry with and without coronary artery disease to address this question. Whole genome sequencing in WUCADS was performed at the McDonnell Genome Institute at Washington University.

pht005833.v1.p1

1 Grupo de itens 2 Elementos de dados

pht005835.v1.p1

1 Grupo de itens 5 Elementos de dados

pht005834.v1.p1

1 Grupo de itens 4 Elementos de dados

Eligibility

1 Grupo de itens 1 Elemento de dados

dbGaP phs001345 NHLBI TOPMed: Genetic Epidemiology Network of Arteriopathy (GENOA) - Eligibility

- 05.03.23 - 4 Formulários, 1 Grupo de itens, 6 Elementos de dados, 1 Idioma
Grupo de itens: IG.elig
Principal Investigator: Sharon L.R. Kardia, PhD, University of Michigan, Ann Arbor, MI, USA MeSH: Hypertension,Aging,Arterial Pressure,Arteriosclerosis,Atherosclerosis,Biomarkers,Blood Pressure,Cardiovascular Diseases,Cholesterol,Cholesterol, HDL,Cholesterol, LDL,Coronary Artery Disease,Diabetes Mellitus,Echocardiography,Endophenotypes,Hyperglycemia,Hyperinsulinism,Hypertrophy, Left Ventricular,Inflammation,Kidney Failure, Chronic,Leukoaraiosis,Lipids,Obesity,Obesity, Abdominal,Peripheral Arterial Disease,Renal Insufficiency, Chronic,Triglycerides,Vascular Calcification https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001345 The Genetic Epidemiology Network of Arteriopathy (GENOA) is one of four networks in the NHLBI Family-Blood Pressure Program (FBPP). GENOA's long-term objective is to elucidate the genetics of target organ complications of hypertension, including both atherosclerotic and arteriolosclerotic complications involving the heart, brain, kidneys, and peripheral arteries. The longitudinal GENOA Study recruited European-American and African-American sibships with at least 2 individuals with clinically diagnosed essential hypertension before age 60 years. All other members of the sibship were invited to participate regardless of their hypertension status. Participants were diagnosed with hypertension if they had either 1) a previous clinical diagnosis of hypertension by a physician with current anti-hypertensive treatment, or 2) an average systolic blood pressure = 140 mm Hg or diastolic blood pressure = 90 mm Hg based on the second and third readings at the time of their clinic visit. Only participants of the African-American Cohort were sequenced through TOPMed. The Family Blood Pressure Program (FBPP), GENOA's parent program, is an unprecedented collaboration to identify genes influencing blood pressure (BP) levels, hypertension, and its target-organ damage. This program has conducted over 21,000 physical examinations, assembled a shared database of several hundred BP and hypertension-related phenotypic measurements, completed genome-wide linkage analyses for BP, hypertension, and hypertension associated risk factors and complications, and published over 130 manuscripts on program findings. The FBPP emerged from what was initially funded as four independent networks of investigators (HyperGEN, GenNet, SAPPHIRe and GENOA) competing to identify genetic determinants of hypertension in multiple ethnic groups. Realizing the greater likelihood of success through collaboration, the investigators created a single confederation with program-wide and network-specific goals. Comprehensive phenotypic data for GENOA study participants are available through dbGaP phs001238.

pht008602.v1.p1

1 Grupo de itens 4 Elementos de dados

pht008603.v1.p1

1 Grupo de itens 2 Elementos de dados

pht008604.v1.p1

1 Grupo de itens 10 Elementos de dados

dbGaP phs000551 Gene expression in CAD - Eligibility

- 13.12.22 - 5 Formulários, 1 Grupo de itens, 1 Elemento de dados, 1 Idioma
Grupo de itens: IG.elig
Principal Investigator: Geoffrey Ginsburg, MD, PhD, Institute for Genome Science and Policy, Duke University, Durham, NC, USA MeSH: Cardiovascular Diseases,Myocardial Infarction,Coronary Artery Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000551 Case control cohort: The details have been previously published: American Heart Journal. 2010;160:371-379 e372. Briefly, a nested case:control cohort of CATHGEN participants who had experienced death or MI (n = 250) after their index catheterization and age-, sex-, and race-matched controls (n = 250) who were free of death/MI 2 years after cardiac catheterization was identified as part of the MURDOCK Horizon 1 Cardiovascular Disease Study.21 Sufficient RNA for microarray analysis was available in 447 members of this cohort. Observational cohort: 224 sequential CATHGEN samples were selected for whole blood RNA analysis, of which, 191 had sufficient RNA for microarray analysis.

pht003061.v1.p1

1 Grupo de itens 2 Elementos de dados

pht003062.v1.p1

1 Grupo de itens 3 Elementos de dados

pht003063.v1.p1

1 Grupo de itens 14 Elementos de dados

pht003064.v1.p1

1 Grupo de itens 3 Elementos de dados

dbGaP phs000514 Identification of Genes Involved in Familial Coronary Artery Disease - Eligibility

- 13.12.22 - 5 Formulários, 1 Grupo de itens, 10 Elementos de dados, 1 Idioma
Grupo de itens: IG.elig
Principal Investigator: Hagit Baris, MD, Rabin Medical Center, Petah Tikva, Israel MeSH: Coronary Artery Disease,Atherosclerosis,Heart Diseases https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000514 Studying families with multiple cases of coronary artery disease (CAD) or with early onset CAD in order to identify new genes involved in CAD in an autosomal dominant manner. After identifying these genes in families that pass on CAD in Mendelian inheritance, we want to pursue their role in the pathogenesis of CAD and their contribution in the general population.

pht002837.v1.p1

1 Grupo de itens 3 Elementos de dados

pht002838.v1.p1

1 Grupo de itens 3 Elementos de dados

pht002839.v1.p1

1 Grupo de itens 2 Elementos de dados

pht002840.v1.p1

1 Grupo de itens 2 Elementos de dados

dbGaP phs000388 IPM BioBank GWAS - pht002351.v1.p1

- 12.10.22 - 4 Formulários, 1 Grupo de itens, 2 Elementos de dados, 1 Idioma
Grupo de itens: pht002351
Principal Investigator: Erwin P. Bottinger, Charles R. Bronfman Institute for Personalized Medicine, Mount Sinai School of Medicine, New York, NY, USA MeSH: Coronary Artery Disease,Chronic Kidney Failure,Diabetes Mellitus, Type 2,Hypertension,Dyslipidemias https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000388 The Institute for Personalized Medicine (IPM) Biobank Project is a consented, EMR-linked medical care setting biorepository of the Mount Sinai Medical Center (MSMC) drawing from a population of over 70,000 inpatients and 800,000 outpatient visits annually. MSMC serves diverse local communities of upper Manhattan, including Central Harlem (86% African American), East Harlem (88% Hispanic Latino), and Upper East Side (88% Caucasian/white) with broad health disparities. IPM Biobank populations include 28% African American (AA), 38% Hispanic Latino (HL) predominantly of Caribbean origin, 23% Caucasian/White (CW). IPM Biobank disease burden is reflective of health disparities with broad public health impact: average body mass index of 28.9 and frequencies of hypertension (55%), hypercholesterolemia (32%), diabetes (30%), coronary artery disease (25%), chronic kidney disease (23%), among others. Biobank operations are fully integrated in clinical care processes, including direct recruitment from clinical sites, waiting areas and phlebotomy stations by dedicated Biobank recruiters independent of clinical care providers, prior to or following a clinician standard of care visit. Recruitment currently occurs at a broad spectrum of over 30 clinical care sites. Minorities are strikingly underrepresented in GWAS, including Coronary Artery Disease (CAD) and Chronic Kidney Disease; multigenic genetic risk scores for CAD have been recently validated in European ancestry populations, but not in AA or HL populations. Several important opportunities exist for extending additional GWAS to minority populations with a shared risk spectrum of CAD and CKD. For example, progressive CKD is a major and independent risk factor for CVD with an inverse relationship between estimated GFR (eGFR), and risk for mortality and cardiovascular events. This increased risk is only partially explained by the prevalence of cardiovascular risk factors among these patients. We conducted a GWAS of CAD and CKD related phenotypes in IPM Biobank with the primary objective to explore the genetics of overlapping CAD and CKD predominantly in minority populations characterized by increased risk.

pht002352.v1.p1

1 Grupo de itens 2 Elementos de dados

pht002353.v1.p1

1 Grupo de itens 9 Elementos de dados

Eligibility

1 Grupo de itens 1 Elemento de dados

dbGaP phs000379 Genetic Epidemiology Network of Arteriopathy (GENOA) - Eligibility

- 12.10.22 - 1 Formulário, 1 Grupo de itens, 4 Elementos de dados, 1 Idioma
Grupo de itens: IG.elig
Principal Investigator: Sharon Kardia, PhD, University of Michigan, Department of Epidemiology, Ann Arbor, MI, USA MeSH: Peripheral Arterial Disease,Coronary Atherosclerosis,Leukoaraiosis,Kidney Diseases https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000379 *The Genetic Epidemiology Network of Arteriopathy (GENOA):* GENOA is one of four research networks that form the NHLBI Family Blood Pressure Program (FBPP). From its inception in 1995, GENOA's long-term objective was to elucidate the genetics of hypertension and its arteriosclerotic target-organ damage, including both atherosclerotic (macrovascular) and arteriolosclerotic (microvascular) complications involving the heart, brain, kidneys, and peripheral arteries. Two GENOA cohorts were originally ascertained (1995-2000) through sibships in which at least 2 siblings had essential hypertension diagnosed prior to age 60 years. All siblings in the sibship were invited to participate, both normotensive and hypertensive. These include non-Hispanic White Americans from Rochester, MN (n =1583 at the 1st exam) and African Americans from Jackson, MS (N=1854 at the 1st exam). During the second exam (2000-2005), approximately 80% of participants were re-recruited. The GENOA data consists of biological samples (DNA, serum, urine) as well as demographic, anthropometric, environmental, clinical, biochemical, physiological, and genetic data for understanding the genetic predictors of diseases of the heart, brain, kidney, and peripheral arteries. *Family Blood Pressure Program (FBPP):* GENOA's parent program, the FBPP, is an unprecedented collaboration to identify genes influencing blood pressure (BP) levels, hypertension, and its target-organ damage. This program has conducted over 21,000 physical examinations, assembled a shared database of several hundred BP and hypertension-related phenotypic measurements, completed genome-wide linkage analyses for BP, hypertension, and hypertension associated risk factors and complications, and published over 130 manuscripts on program findings. The FBPP emerged from what was initially funded as four independent networks of investigators (HyperGEN, GenNet, SAPPHIRe and GENOA) competing to identify genetic determinants of hypertension in multiple ethnic groups. Realizing the greater likelihood of success through collaboration, the investigators began working together during the first funding cycle (1995-2000) and formalized this arrangement in the second cycle (2000-2005), creating a single confederation with program-wide and network-specific goals.

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