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dbGaP phs000289 NHGRI Genome-Wide Association Study of Venous Thromboembolism (GWAS of VTE) - pht001883.v1.p1

- 12/10/22 - 5 Formulieren, 1 Itemgroep, 4 Data-elementen, 1 Taal

Itemgroep: pht001883

Principal Investigator: John A. Heit, MD, Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA MeSH: Venous Thrombosis,Pulmonary Embolism,Deep Vein Thrombosis,Thrombophlebitis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000289 *Overview:* *Our overall long-term goal is to determine risk factors for the complex (multifactorial) disease, venous thromboembolism (*VTE*), that will allow physicians to stratify individual patient risk and target VTE prophylaxis to those who would benefit most.* In this genome-wide association case-control study (1300 cases and 1300 controls) we hope to identify susceptibility variants for VTE. Mutations within genes encoding for important components of the anticoagulant, procoagulant, fibrinolytic, and innate immunity pathways are risk factors for VTE. We hypothesize that other genes within these four pathways or within other pathways also are VTE disease-susceptibility genes. Therefore, we performed a genome wide association (GWA) screen and analysis using the Illumina 660W platform to identify SNPs within 1,300 clinic-based, non-cancer VTE cases primarily from Minnesota and the upper Midwest USA, and 1300 clinic-based, unrelated controls frequency-matched on patient age, gender, myocardial infarction/stroke status and state of residence. This is a subset of a slightly larger candidate gene study using 1500 case-control pairs to identify haplotype-tagging SNPs (*ht*-SNPs) in a large set of candidate genes (n~750) within the anticoagulant, procoagulant, fibrinolytic, and innate immunity pathways. *Study Populations.* **Cases*.* VTE cases were consecutive Mayo Clinic outpatients with objectively-diagnosed deep vein thrombosis (DVT) and/or pulmonary embolism (PE) residing in the upper Midwest and referred by Mayo Clinic physician to the Mayo Clinic Special Coagulation Laboratory for clinical diagnostic testing to evaluate for an acquired or inherited thrombophilia, or to the Mayo Clinic Thrombophilia Center. Any person contacted to be a control but discovered to have had a VTE was evaluated for inclusion as a case. Cases were primarily residents from Minnesota, Wisconsin, Iowa, Michigan, Illinois, North or South Dakota, Nebraska, Kansas, Missouri and Indiana. A DVT or PE was categorized as objectively diagnosed when (a) confirmed by venography or pulmonary angiography, or pathology examination of thrombus removed at surgery, or (b) if at least one non-invasive test (compression duplex ultrasonography, lung scan, computed tomography scan, magnetic resonance imaging) was positive. A VTE was defined as:- Proximal leg deep vein thrombosis (DVT), which includes the common iliac, internal iliac, external iliac, common femoral, superficial [now termed "femoral"] femoral, deep femoral [sometimes referred to as "profunda" femoral] and/or popliteal veins. (Note: greater and lesser saphenous veins, or other superficial or perforator veins, were not included as proximal or distal leg DVT). - Distal leg DVT (or "isolated calf DVT"), which includes the anterior tibial, posterior tibial and/or peroneal veins. (Note: gastrocnemius, soleal and/or sural [e.g., "deep muscular veins" of the calf] vein thrombosis was not included as distal leg DVT). - Arm DVT, which includes the axillary, subclavian and/or innominate (brachiocephalic) veins. (Note: jugular [internal or external], cephalic and brachial vein thrombosis was not included in "arm DVT"). - Hepatic, portal, splenic, superior or inferior mesenteric, and/or renal vein thrombosis. (Note: ovarian, testicular, peri-prostatic and/or pelvic vein thrombosis was not included). - Cerebral vein thrombosis (includes cerebral or dural sinus or vein, saggital sinus or vein, and/or transverse sinus or vein thrombosis). - Inferior vena cava (IVC) thrombosis - Superior vena cava (SVC) thrombosis - Pulmonary embolism Patients with VTE related to active cancer, antiphospholipid syndrome, inflammatory bowel disease, vasculitis, a rheumatoid or other autoimmune disorder, a vascular anomaly (e.g., Klippel-Trénaunay syndrome, etc.), heparin-induced thrombocytopenia, or a mechanical cause for DVT (e.g., arm DVT or SVC thrombosis related to a central venous catheter or transvenous pacemaker, portal and/or splenic vein thrombosis related to liver cirrhosis, IVC thrombosis related to retroperitoneal fibrosis, etc.), with hemodialysis arteriovenous fistula thrombosis, or with prior liver or bone marrow transplantation were excluded. **Controls*.* A Mayo Clinic outpatient control group was prospectively recruited for this study. Controls were frequency-matched on the age group (18-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80+ years), sex, myocardial infarction/stroke status, and state of residence distribution of the cases. We selected clinic-based controls using a controls' database of persons undergoing general medical examinations in the Mayo Clinic Departments of General Internal Medicine or Primary Care Internal Medicine. Additionally persons undergoing evaluation at the Mayo Clinic Sports Medicine Center, and the Department of Family Medicine were screened for inclusion as controls. 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 venous thrombosis through large-scale genome-wide association studies of 1,300 clinic-based, VTE cases and 1300 clinic-based, unrelated controls. Genotyping was performed at the Johns Hopkins University Center for Inherited Disease Research (CIDR). Data cleaning and harmonization were done at the GEI-funded GENEVA Coordinating Center at the University of Washington.

Venous Thrombosis

pht001884.v1.p1

1 Itemgroep 6 Data-elementen

pht001885.v1.p1

1 Itemgroep 4 Data-elementen

Eligibility

1 Itemgroep 12 Data-elementen

pht001886.v2.p1

1 Itemgroep 39 Data-elementen

Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619 - Unscheduled Assessment of Symptomatic DVT

- 22/10/18 - 1 Formulier, 4 Itemgroepen, 18 Data-elementen, 1 Taal

Itemgroepen: Deep Vein Thrombosis; Evaluation, Ultrasonography, Venography, Deep Vein Thrombosis, Pharmaceutical Preparations

Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous

dbGaP phs000993 NHLBI TOPMed: Heart and Vascular Health Study (HVH) - Eligibility

- 25/11/23 - 4 Formulieren, 1 Itemgroep, 2 Data-elementen, 1 Taal

Itemgroep: IG.elig

Principal Investigator: Susan R. Heckbert, MD, PhD, University of Washington, Seattle, WA, USA MeSH: Cardiovascular Disease,Venous Thrombosis,Atrial Fibrillation https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000993 *Objectives*br The Heart and Vascular Health Study (HVH) is a case-control study of risk factors for the development of myocardial infarction (MI), stroke, venous thrombosis (VT), and atrial fibrillation (AF). The study setting is Group Health, an integrated health care delivery system in Washington State. Only VT cases and early-onset AF cases are included as part of TOPMed. *Background*br The HVH study originated in 1988 with the examination of risk factors for MI. Over the ensuing years, the study has been funded by a series of grants which have added case subjects with stroke, VT, and AF. Study aims focused on the associations of medication use with cardiovascular events, and starting in 1997, the study aims expanded to include genetic associations with cardiovascular disease. Participants recruited in 2009 or later who provided blood samples for genetic analysis were asked for consent to deposit genetic and phenotypic data in dbGaP. *Design*br As part of the HVH study, case subjects were identified by searching for ICD-9 codes consistent with MI, stroke, VT, or AF, and medical records were reviewed to confirm the diagnosis. Control subjects were identified at random from the Group Health enrollment and were matched to MI cases. All subjects have an index date. For cases, the index date was assigned as the date that the cardiovascular event (MI, stroke, VT, or AF) came to clinical attention. For controls, the index date was a random date within the range of the case index dates. For both cases and controls, information was collected from the inpatient and outpatient medical record, by telephone interview with consenting survivors, and from the Group Health pharmacy and laboratory databases. Consenting participants provided a blood specimen. *Subjects*br Only VT and early-onset AF cases from HVH are included in TOPMed. Within the HVH study, VT and AF cases were diagnosed in both inpatient and outpatient settings, and only incident cases are eligible for inclusion in TOPMed. *Genetic Research*br Genetic factors underlying cardiovascular disease are studied using DNA isolated from the blood samples. Phenotype data for HVH study participants are available through dbGaP phs001013.

pht005014.v3.p2

1 Itemgroep 2 Data-elementen

pht005013.v2.p2

1 Itemgroep 3 Data-elementen

pht005015.v2.p2

1 Itemgroep 9 Data-elementen

dbGaP phs001368 NHLBI TOPMed: Trans-Omics for Precision Medicine (TOPMed) Whole Genome Sequencing Project: Cardiovascular Health Study - Eligibility

- 21/02/23 - 4 Formulieren, 1 Itemgroep, 4 Data-elementen, 1 Taal

Itemgroep: IG.elig

Principal Investigator: Bruce M. Psaty, MD, PhD, TOPMed Cardiovascular Health Study Project (TOPMed-CHS). University of Washington, Seattle, WA, USA MeSH: Cardiovascular Diseases,Myocardial Infarction,Stroke,Brain Ischemia,Intracranial Hemorrhage,Venous Thromboembolism,Venous Thrombosis,Pulmonary Embolism https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001368 Participants from the Cardiovascular Health Study (CHS), a large population-based longitudinal cohort study (phs000287), have been included in the TOPMed project. Whole genome sequencing will be performed to contribute to multiple analyses, including cardiovascular disease risk factors, subclinical disease measures, the occurrence of myocardial infarction (MI) and stroke, and analyses of venous thromboembolism (VTE).

pht007957.v3.p2

1 Itemgroep 3 Data-elementen

pht007958.v3.p2

1 Itemgroep 2 Data-elementen

pht007959.v3.p2

1 Itemgroep 12 Data-elementen

dbGaP phs001376 Autosomal Recessive CD55 Deficiency - pht006552.v1.p1

- 07/02/23 - 6 Formulieren, 1 Itemgroep, 5 Data-elementen, 1 Taal

Itemgroep: pht006552

Principal Investigator: Michael Lenardo, National Institute of Allergy and Infectious Diseases, National Health Institure, Bethesda, MD, USA MeSH: Protein-Losing Enteropathies,Lymphangiectasis, Intestinal,Venous Thrombosis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001376 We describe 11 patients from 8 families with homozygous LOF mutations in the complement regulatory protein CD55. Loss of CD55 is associated with increased complement activation, severe protein losing enteropathy accompanying a primary intestinal lymphangiectasia, and deep vein thrombotic events. We have named this disease CHAPLE after the principle components of the disease.

pht006553.v1.p1

1 Itemgroep 3 Data-elementen

pht006554.v1.p1

1 Itemgroep 9 Data-elementen

pht006555.v1.p1

1 Itemgroep 5 Data-elementen

pht006551.v1.p1

1 Itemgroep 3 Data-elementen

Eligibility

1 Itemgroep 5 Data-elementen

Input Data Elements CDSS VTE prophylaxis Galanter 2010

- 07/10/16 - 1 Formulier, 1 Itemgroep, 30 Data-elementen, 1 Taal

Itemgroep: VTE prophylaxis

Input Data Elements CDSS for VTE prophylaxis to evaluate the effect of an implementation of a CDSS on thromboembolism risk assessment, prophylaxis and prevention. Published by Galanter et al. 2010

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Suspected DVT Adjudication

- 16/09/19 - 1 Formulier, 6 Itemgroepen, 19 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Suspected DVT Adjudication, Suspected DVT Adjudication Results, Venography Adjudication Results, Classification, Adjudicators

Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form contains information on the adjudication of any suspected DVT, information on which is recorded in a seperate form.

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