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dbGaP phs000974 NHLBI TOPMed: Whole Genome Sequencing and Related Phenotypes in the Framingham Heart Study - Eligibility

- 01-12-23 - 4 Formulieren, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Vasan Ramachandran, Department of Medicine, Boston University School of Medicine, Boston, MA, USA MeSH: Cardiovascular Diseases,Atherosclerosis,Atrial Fibrillation,Death, Sudden, Cardiac,Diabetes Mellitus, Type 2,Heart Failure,Blood Pressure,Hypertension,Body Mass Index,Adiposity,Lipids,Pulmonary Disease, Chronic Obstructive,Renal Insufficiency, Chronic,Stroke,Osteoporosis,Risk Factors,Biological Markers,Biomarkers, Pharmacological https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000974 The Framingham Heart Study (FHS) is a prospective cohort study of 3 generations of subjects who have been followed up to 65 years to evaluate risk factors for cardiovascular disease. Its large sample of ~15,000 men and women who have been extensively phenotyped with repeated examinations make it ideal for the study of genetic associations with cardiovascular disease risk factors and outcomes. DNA samples have been collected and immortalized since the mid-1990s and are available on ~8000 study participants in 1037 families. These samples have been used for collection of GWAS array data and exome chip data in nearly all with DNA samples, and for targeted sequencing, deep exome sequencing and light coverage whole genome sequencing in limited numbers. Additionally, mRNA and miRNA expression data, DNA methylation data, metabolomics and other 'omics data are available on a sizable portion of study participants. This project will focus on deep whole genome sequencing (mean 30X coverage) in ~4100 subjects and imputed to all with GWAS array data to more fully understand the genetic contributions to cardiovascular, lung, blood and sleep disorders. Comprehensive phenotypic and pedigree data for study participants are available through dbGaP phs000007.

pht004909.v3.p3

1 Itemgroep 2 Data-elementen

pht004910.v4.p3

1 Itemgroep 2 Data-elementen

pht004911.v3.p3

1 Itemgroep 9 Data-elementen

dbGaP phs000971 The ClinSeq Project: Piloting Large-Scale Genome Sequencing for Research in Genomic Medicine - pht004916.v2.p1

- 29-06-23 - 5 Formulieren, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: pht004916
Principal Investigator: Leslie G. Biesecker, MD, National Institutes of Health, Bethesda, MD, USA MeSH: Atherosclerosis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000971 ClinSeq is a pilot project to investigate the use of whole-genome sequencing as a tool for clinical research. By piloting the acquisition of large amounts of DNA sequence data from individual human subjects, we are fostering the development of hypothesis-generating approaches for performing research in genomic medicine, including the exploration of issues related to the genetic architecture of disease, implementation of genomic technology, informed consent, disclosure of genetic information, and archiving, analyzing, and displaying sequence data. In the initial phase of ClinSeq, we are enrolling roughly 1000 participants; the evaluation of each includes obtaining a detailed family and medical history, as well as a clinical evaluation. The participants are being consented broadly for research on many traits and for whole-genome sequencing. Initially, Sanger-based sequencing of 300-400 genes thought to be relevant to atherosclerosis is being performed, with the resulting data analyzed for rare, high-penetrance variants associated with specific clinical traits. The participants are also being consented to allow the contact of family members for additional studies of sequence variants to explore their potential association with specific phenotypes. Here, we present the general considerations in designing ClinSeq, preliminary results based on the generation of an initial 826 Mb of sequence data, the findings for several genes that serve as positive controls for the project, and our views about the potential implications of ClinSeq. The early experiences with ClinSeq illustrate how large-scale medical sequencing can be a practical, productive, and critical component of research in genomic medicine. Reprinted from Genome Res. 2009 Sep; 19(9): 1665-1674, with permission from Genome Research, PMID: 19602640.

pht004917.v3.p1

1 Itemgroep 2 Data-elementen

pht004918.v2.p1

1 Itemgroep 178 Data-elementen

Eligibility

1 Itemgroep 1 Data-element

pht004919.v3.p1

1 Itemgroep 5 Data-elementen

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

- 05-03-23 - 4 Formulieren, 1 Itemgroep, 6 Data-elementen, 1 Taal
Itemgroep: 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 Itemgroep 4 Data-elementen

pht008603.v1.p1

1 Itemgroep 2 Data-elementen

pht008604.v1.p1

1 Itemgroep 10 Data-elementen

dbGaP phs000309 The CARDIA-GENEVA Study - Eligibility

- 13-12-22 - 4 Formulieren, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Cora E. Lewis, MD, University of Alabama at Birmingham, Birmingham, AL, USA MeSH: Cardiovascular Diseases,Hypertension,Atherosclerosis,Obesity,Lipids,Diabetes Mellitus,Smoking,Pulmonary Function Test,Physical Activities,Energy Intake,Diet https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000309 *For the GENEVA CARDIA project, three genotype call sets were generated from a single set of array scans as a consequence of DNA sample quality problems. These call sets are designated "Birdsuite-1", "Birdsuite-2" and "Beaglecall". ("Beaglecall" used both Birdseed and BEAGLECALL calling algorithms.) An analysis-ready genotypic data set is provided in PLINK format for the "Beaglecall" set only, because it performs very well in QC analyses. Only raw CHP and ALLELE_SUMMARY files are provided for the two Birdsuite call sets because they have significant quality issues. Use of the Beaglecall set is highly recommended. Users of the other two call sets should proceed with caution. More details are given in the genotypic QC report.* The CARDIA study, sponsored by the National Heart, Lung and Blood Institute (NHLBI), is a prospective, multi-center investigation of the natural history and etiology of cardiovascular disease in African-Americans and Whites 18-30 years of age at the time of initial examination. The initial examination included 5,115 participants selectively recruited to represent proportionate racial, gender, age, and education groups from 4 communities: Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA. Participants from the Birmingham, Chicago, and Minneapolis centers were recruited from the total community or from selected census tracts. Participants from the Oakland center were randomly recruited from the Kaiser-Permanente health plan membership. From the time of initiation of the study in 1985-1986, five follow-up examinations have been conducted at years 2, 5, 7, 10, 15, and 20. The Year 25 examination is scheduled to begin in 2010. This study is part of the Gene Environment Association Studies initiative (GENEVA, http://www.genevastudy.org) funded by the trans-NIH Genes, Environment, and Health Initiative (GEI). The overarching goal is to identify novel genetic factors associated with variation in longitudinal blood pressure profiles during the critical transition period from young adulthood to early middle-age; and to characterize their interactions with relevant environmental factors, such as body weight profiles. Genotyping was performed at the Broad Institute of MIT and Harvard, a GENEVA genotyping center. Data cleaning and harmonization were performed at the GEI-funded GENEVA Coordinating Center at the University of Washington.

pht001997.v2.p2

1 Itemgroep 4 Data-elementen

pht001999.v2.p2

1 Itemgroep 151 Data-elementen

pht001998.v2.p2

1 Itemgroep 4 Data-elementen

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

- 13-12-22 - 5 Formulieren, 1 Itemgroep, 10 Data-elementen, 1 Taal
Itemgroep: 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 Itemgroep 3 Data-elementen

pht002838.v1.p1

1 Itemgroep 3 Data-elementen

pht002839.v1.p1

1 Itemgroep 2 Data-elementen

pht002840.v1.p1

1 Itemgroep 2 Data-elementen

dbGaP phs000090 The Atherosclerosis Risk in Communities (ARIC) Study - pht001035.v1.p1

- 12-10-22 - 3 Formulieren, 1 Itemgroep, 4 Data-elementen, 1 Taal
Itemgroep: pht001035.v1.p1
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000090 The Atherosclerosis Risk in Communities (ARIC) Study, sponsored by the National Heart, Lung and Blood Institute (NHLBI), is a prospective epidemiologic study conducted in four U.S. communities. The four communities are Forsyth County, NC; Jackson, MS; the northwest suburbs of Minneapolis, MN; and Washington County, MD. ARIC is designed to investigate the etiology and natural history of atherosclerosis, the etiology of clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care and disease by race, gender, location, and date. ARIC includes two parts: the Cohort Component and the Community Surveillance Component. The Cohort Component began in 1987, and each ARIC field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community. A total of 15,792 participants received an extensive examination, including medical, social, and demographic data. These participants were reexamined every three years with the first screen (baseline) occurring in 1987-89, the second in 1990-92, the third in 1993-95, and the fourth and last exam was in 1996-98. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. In the Community Surveillance Component, currently ongoing, these four communities are investigated to determine the community-wide occurrence of hospitalized myocardial infarction and coronary heart disease deaths in men and women aged 35-84 years. Hospitalized stroke is investigated in cohort participants only. Starting in 2006, the study conducts community surveillance of inpatient (ages 55 years and older) and outpatient heart failure (ages 65 years and older) for heart failure events beginning in 2005. ARIC is currently funded through January 31, 2012. This study is part of the Gene Environment Association Studies initiative (GENEVA, http://www.genevastudy.org) funded by the trans-NIH Genes, Environment, and Health Initiative (GEI). The overarching goal is to identify novel genetic factors that contribute to atherosclerosis and cardiovascular disease through large-scale genome-wide association studies of well-characterized cohorts of adults in four defined populations. Genotyping was performed at the Broad Institute of MIT and Harvard, a GENEVA genotyping center. Data cleaning and harmonization were done at the GEI-funded GENEVA Coordinating Center at the University of Washington.

pht000114.v1.p1

1 Itemgroep 362 Data-elementen

pht001036.v1.p1

1 Itemgroep 4 Data-elementen

dbGaP phs000349 SNPs and Extent of Atherosclerosis (SEA) Study - pht002189.v1.p1

- 12-10-22 - 4 Formulieren, 1 Itemgroep, 5 Data-elementen, 1 Taal
Itemgroep: pht002189
Principal Investigator: David Herrington, MD, MHS, Wake Forest University Baptist Medical Center, Winston Salem, NC, USA MeSH: Atherosclerosis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000349 The SEA study is a genome-wide association study to identify genetic variants associated with premature atherosclerosis in subjects included in the Pathobiological Determinants of Atherosclerosis in Youth (PDAY) repository - a unique NHLBI resource including data, DNA and arterial specimens from over 3000 multi-ethnic subjects 15-34 years of age who died of non-atherosclerotic causes (mostly trauma). All PDAY subjects had post-mortem quantitative assessment of raised atherosclerotic lesions in their aorta and coronary arteries - making this the largest and most carefully phenotyped cohort for premature atherosclerosis in the world. The goal of the current project was to use the quantitative measure of raised atherosclerotic lesions in the PDAY cohort as the target phenotype for a genome-wide association study and to use quantitative measures of subclinical atherosclerosis (coronary calcium and carotid IMT) in the Multi-Ethnic Study of Atherosclerosis (MESA) to confirm or refute candidate loci identified from the PDAY analysis. Identifying genetic factors that predispose individuals to premature atherosclerosis could lead to more effective screening and early treatment of high risk individuals and suggest novel molecular targets for treatment and prevention interventions.

pht002191.v1.p1

1 Itemgroep 14 Data-elementen

pht002190.v1.p1

1 Itemgroep 2 Data-elementen

Eligibility

1 Itemgroep 5 Data-elementen

Chronic Mesenteric Artery Disease data elements

- 20-09-21 - 1 Formulier, 10 Itemgroepen, 37 Data-elementen, 2 Talen
Itemgroepen: Patient history, Physical examination, Laboratory Testing, Diagnosis, Noninvasive, Diagnostics, invasive, Therapeutic Procedures, Outcomes, Patient education, Follow-up, Outcomes
2012 ACCF / AHA Data Standard Chronic Mesenteric Artery Disease data elements see http://www.ncbi.nlm.nih.gov/pubmed/22144570

Extracranial Carotid and Vertebral Artery Disease data elements

- 13-04-21 - 1 Formulier, 9 Itemgroepen, 52 Data-elementen, 2 Talen
Itemgroepen: Patient history, Anatomic High-Risk Conditions, Comorbitiy, cardiopulmonary, Patient assessment, Diagnostic Procedures, Therapeutic Procedures, invasive, Outcomes, Patient education, Outcomes
2012 ACCF / AHA Data Standard Extracranial Carotid and Vertebral Artery Disease data elements see http://www.ncbi.nlm.nih.gov/pubmed/22144570

Darapladib Evaluation Case Report Form GSK LPL107988 - Investigational Product

- 15-09-19 - 12 Formulieren, 4 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Randomisation Number, Investigational Product Exposure, Treatment Confirmation
Two-Part Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Oral Dosesof the Enteric-Coated Free Base Formulation of Darapladib (SB-480848) ina Dose Rising Fashion and to Evaluate the Safety, Tolerability and Pharmacokinetics of Darapladib when Co-administered with Ketoconazole in Healthy Adult Subjects. There are 4 parts to this study: Screening, Part A, Part B, and Follow-Up. Part A contains 2 Sessions per day for day 1-10, Part B contains 1 Session per day for day 1-14. Each itemgroup contains information when it should be filled out. The itemgroups of the non-serious and serious adverse event forms contain additional information on the definition of a serious/non-serious adverse event.

Study Conclusion

5 Itemgroepen 23 Data-elementen

Laboratory Results

4 Itemgroepen 7 Data-elementen

Eligibility Criteria

4 Itemgroepen 23 Data-elementen

Concomitant Medication

3 Itemgroepen 13 Data-elementen

Non-serious adverse events

3 Itemgroepen 12 Data-elementen

ECG

5 Itemgroepen 19 Data-elementen

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Subject Identification; Electronically Transferred Lab Data

- 14-08-19 - 1 Formulier, 8 Itemgroepen, 34 Data-elementen, 1 Taal
Itemgroepen: Inform Screening, Subject number, Date of Visit/ Assessment, Demography, 12-Lead ECG, Vital Signs, Subject identification, Electronically Transferred Lab Data
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Liver Event - Liver Events; Investigational Product; Pharmacokinetics; Medical Conditions; Alcohol Intake; Liver Imaging; Liver Biopsy

- 08-05-19 - 1 Formulier, 13 Itemgroepen, 104 Data-elementen, 1 Taal
Itemgroepen: Date of Visit, Liver Event Assessment, Liver Events, Investigational Product (Liver) - during treatment period, Investigational Product (Liver) - after treatment period , Pharmacokinetics (Liver PK), Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake, Liver imaging, Liver Biopsy
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

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