ID

45695

Descripción

Principal Investigator: Rasika A. Mathias, ScD, Johns Hopkins University School of Medicine, Baltimore, MD, USA MeSH: Platelet Aggregation,Blood Physiological Phenomena,Cardiovascular Physiological Phenomena https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001218 GeneSTAR began in 1982 as the Johns Hopkins Sibling and Family Heart Study, a prospective longitudinal family-based study conducted originally in healthy adult siblings of people with documented early onset coronary disease under 60 years of age. Commencing in 2003, the siblings, their offspring, and the coparent of the offspring participated in a 2 week trial of aspirin 81 mg/day with pre and post ex vivo platelet function assessed using multiple agonists in whole blood and platelet rich plasma. Extensive additional cardiovascular testing and risk assessment was done at baseline and serially. Follow-up was carried out to determine incident cardiovascular disease, stroke, peripheral arterial disease, diabetes, cancer, and related comorbidities, from 5 to 30 years after study entry. The goal of several additional phenotyping and interventional substudies has been to discover and amplify understanding of the mechanisms of atherogenic vascular diseases and attendant comorbidities.

Link

dbGaP-study=phs001218

Palabras clave

Versiones (1)
  1. 10/05/2023 10/05/2023 - Chiara Middel
Titular de derechos de autor

Rasika A. Mathias, ScD, Johns Hopkins University School of Medicine, Baltimore, MD, USA

Subido en

10 mai 2023

DOI

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Licencia

Creative Commons BY 4.0
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dbGaP phs001218 NHLBI TOPMed: Genetic Study of Atherosclerosis Risk (GeneSTAR)

Inglés

Eligibility Criteria

6 formularios  
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. The subject consent data table contains subject IDs, consent group information, and subject aliases.
    3. This pedigree data table contains family relationships in the format of family IDs, subject IDs, father IDs, mother IDs, sex of subjects, and twin IDs for monozygotic twins.
    4. This subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs.
    5. This sample attributes table includes body site where sample was collected, analyte type, tumor status, sequencing center, funding source, TOPMed phase, project, and study name.
    6. This subject phenotypes data table includes study visit, anthropometric measurements (n=4 variables; height, BMI, waist, and hip), blood pressure (n=6 variables; systolic, diastolic, and ankle-brachial), medications (n=4 variables; blood pressure, hypertension, diabetes, and lipid), blood measurements (n=99 variables; cholesterol, blood factors, rbc, wbc, whole blood, platelet rich plasma, aggregation for epinephrine or ADP, inflammatory markers), urinary creatinine, menstruation and menopause status (n=3 variables), CT measurements (n=2 variables), food intake, carbon monoxide exposure, and smoking status (n=7 variables).
Inclusion and exclusion criteria
Descripción

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*Inclusion*: Persons were eligible if they had been a participant in GeneSTAR (examining the effect of 81 mg of aspirin daily for 2 weeks on platelet function with pre and post aspirin platelet testing). All subjects were: 1) offspring of a sibling identified in the SIB study, > 21 years of age, 2) a sibling identified in The Johns Hopkins Sibling Study, or 3) a spouse or co-parent of any offspring. All of these subjects underwent a GWAS to be selected for TOPMed.
Descripción

Elig.phs001218.v3.p1.1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1516637
UMLS CUI [1,3]
C1997894
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C0008976
UMLS CUI [2,1]
C0680063
UMLS CUI [2,2]
C0037047
UMLS CUI [2,3]
C0205396
UMLS CUI [2,4]
C0205394
UMLS CUI [2,5]
C0008976
UMLS CUI [2,6]
C0001779
UMLS CUI [3,1]
C0037047
UMLS CUI [3,2]
C0205396
UMLS CUI [3,3]
C0205394
UMLS CUI [3,4]
C0008976
UMLS CUI [4,1]
C0162409
UMLS CUI [4,2]
C0030551
UMLS CUI [4,3]
C0680063
UMLS CUI [5,1]
C0681850
UMLS CUI [5,2]
C2350277
UMLS CUI [5,3]
C0242802
UMLS CUI [5,4]
C0008976
*Exclusion*: For the parent study these included the following: 1) the presence of any coronary heart disease or vascular thrombotic event, 2) any bleeding disorder or any hemorrhagic event in the past (stroke, gastrointestinal bleed), 3) use of any anticoagulants or anti-platelet agents (i.e. warfarin, persantin, clopidogrel), 4) chronic or acute nonsteroidal anti-inflammatory agents, including COX-2 inhibitors that could not be discontinued, 5) recent active gastrointestinal disorder, 6) current pharmacotherapy for a gastrointestinal disorder, 7) pregnancy or risk of pregnancy during the treatment trial, 8) recent menorrhagia, 9) known aspirin intolerance or allergic side effects, 10) serious medical disorders, including autoimmune diseases, renal or hepatic failure, cancer or HIV-AIDS, 11) chronic or acute use of glucocorticosteroid therapy or any drug that may interfere with the measured outcomes, 12) serious psychiatric disorders, and, 13) unable to independently make a decision to participate.
Descripción

Elig.phs001218.v3.p1.2

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [2,1]
C0010068
UMLS CUI [2,2]
C1801960
UMLS CUI [2,3]
C0040053
UMLS CUI [3,1]
C0005779
UMLS CUI [3,2]
C0019087
UMLS CUI [4,1]
C0003280
UMLS CUI [4,2]
C0085826
UMLS CUI [5,1]
C0003211
UMLS CUI [5,2]
C1257954
UMLS CUI [5,3]
C1299582
UMLS CUI [5,4]
C0443239
UMLS CUI [6,1]
C0332185
UMLS CUI [6,2]
C0017178
UMLS CUI [7,1]
C0521116
UMLS CUI [7,2]
C0013216
UMLS CUI [7,3]
C0017178
UMLS CUI [8,1]
C0032961
UMLS CUI [8,2]
C0425965
UMLS CUI [8,3]
C0347984
UMLS CUI [8,4]
C0008976
UMLS CUI [9,1]
C0332185
UMLS CUI [9,2]
C0025323
UMLS CUI [10,1]
C0004058
UMLS CUI [10,2]
C0020517
UMLS CUI [11,1]
C0205404
UMLS CUI [11,2]
C0221423
UMLS CUI [11,3]
C0004364
UMLS CUI [11,4]
C0035078
UMLS CUI [11,5]
C0085605
UMLS CUI [11,6]
C0442867
UMLS CUI [11,7]
C0019682
UMLS CUI [12,1]
C0205191
UMLS CUI [12,2]
C0205178
UMLS CUI [12,3]
C1524063
UMLS CUI [12,4]
C0038317
UMLS CUI [12,5]
C0013227
UMLS CUI [12,6]
C0521102
UMLS CUI [12,7]
C0444706
UMLS CUI [12,8]
C2015879
UMLS CUI [13,1]
C0205404
UMLS CUI [13,2]
C0004936
UMLS CUI [14,1]
C1299582
UMLS CUI [14,2]
C0021430
UMLS CUI [14,3]
C0679823
UMLS CUI [14,4]
C0008976
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Similar models

Eligibility Criteria

6 formularios
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. The subject consent data table contains subject IDs, consent group information, and subject aliases.
    3. This pedigree data table contains family relationships in the format of family IDs, subject IDs, father IDs, mother IDs, sex of subjects, and twin IDs for monozygotic twins.
    4. This subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs.
    5. This sample attributes table includes body site where sample was collected, analyte type, tumor status, sequencing center, funding source, TOPMed phase, project, and study name.
    6. This subject phenotypes data table includes study visit, anthropometric measurements (n=4 variables; height, BMI, waist, and hip), blood pressure (n=6 variables; systolic, diastolic, and ankle-brachial), medications (n=4 variables; blood pressure, hypertension, diabetes, and lipid), blood measurements (n=99 variables; cholesterol, blood factors, rbc, wbc, whole blood, platelet rich plasma, aggregation for epinephrine or ADP, inflammatory markers), urinary creatinine, menstruation and menopause status (n=3 variables), CT measurements (n=2 variables), food intake, carbon monoxide exposure, and smoking status (n=7 variables).
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Elig.phs001218.v3.p1.1
Item
*Inclusion*: Persons were eligible if they had been a participant in GeneSTAR (examining the effect of 81 mg of aspirin daily for 2 weeks on platelet function with pre and post aspirin platelet testing). All subjects were: 1) offspring of a sibling identified in the SIB study, > 21 years of age, 2) a sibling identified in The Johns Hopkins Sibling Study, or 3) a spouse or co-parent of any offspring. All of these subjects underwent a GWAS to be selected for TOPMed.
boolean
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C1997894 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C0680063 (UMLS CUI [2,1])
C0037047 (UMLS CUI [2,2])
C0205396 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
C0008976 (UMLS CUI [2,5])
C0001779 (UMLS CUI [2,6])
C0037047 (UMLS CUI [3,1])
C0205396 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
C0008976 (UMLS CUI [3,4])
C0162409 (UMLS CUI [4,1])
C0030551 (UMLS CUI [4,2])
C0680063 (UMLS CUI [4,3])
C0681850 (UMLS CUI [5,1])
C2350277 (UMLS CUI [5,2])
C0242802 (UMLS CUI [5,3])
C0008976 (UMLS CUI [5,4])
Elig.phs001218.v3.p1.2
Item
*Exclusion*: For the parent study these included the following: 1) the presence of any coronary heart disease or vascular thrombotic event, 2) any bleeding disorder or any hemorrhagic event in the past (stroke, gastrointestinal bleed), 3) use of any anticoagulants or anti-platelet agents (i.e. warfarin, persantin, clopidogrel), 4) chronic or acute nonsteroidal anti-inflammatory agents, including COX-2 inhibitors that could not be discontinued, 5) recent active gastrointestinal disorder, 6) current pharmacotherapy for a gastrointestinal disorder, 7) pregnancy or risk of pregnancy during the treatment trial, 8) recent menorrhagia, 9) known aspirin intolerance or allergic side effects, 10) serious medical disorders, including autoimmune diseases, renal or hepatic failure, cancer or HIV-AIDS, 11) chronic or acute use of glucocorticosteroid therapy or any drug that may interfere with the measured outcomes, 12) serious psychiatric disorders, and, 13) unable to independently make a decision to participate.
boolean
C0680251 (UMLS CUI [1,1])
C0010068 (UMLS CUI [2,1])
C1801960 (UMLS CUI [2,2])
C0040053 (UMLS CUI [2,3])
C0005779 (UMLS CUI [3,1])
C0019087 (UMLS CUI [3,2])
C0003280 (UMLS CUI [4,1])
C0085826 (UMLS CUI [4,2])
C0003211 (UMLS CUI [5,1])
C1257954 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C0443239 (UMLS CUI [5,4])
C0332185 (UMLS CUI [6,1])
C0017178 (UMLS CUI [6,2])
C0521116 (UMLS CUI [7,1])
C0013216 (UMLS CUI [7,2])
C0017178 (UMLS CUI [7,3])
C0032961 (UMLS CUI [8,1])
C0425965 (UMLS CUI [8,2])
C0347984 (UMLS CUI [8,3])
C0008976 (UMLS CUI [8,4])
C0332185 (UMLS CUI [9,1])
C0025323 (UMLS CUI [9,2])
C0004058 (UMLS CUI [10,1])
C0020517 (UMLS CUI [10,2])
C0205404 (UMLS CUI [11,1])
C0221423 (UMLS CUI [11,2])
C0004364 (UMLS CUI [11,3])
C0035078 (UMLS CUI [11,4])
C0085605 (UMLS CUI [11,5])
C0442867 (UMLS CUI [11,6])
C0019682 (UMLS CUI [11,7])
C0205191 (UMLS CUI [12,1])
C0205178 (UMLS CUI [12,2])
C1524063 (UMLS CUI [12,3])
C0038317 (UMLS CUI [12,4])
C0013227 (UMLS CUI [12,5])
C0521102 (UMLS CUI [12,6])
C0444706 (UMLS CUI [12,7])
C2015879 (UMLS CUI [12,8])
C0205404 (UMLS CUI [13,1])
C0004936 (UMLS CUI [13,2])
C1299582 (UMLS CUI [14,1])
C0021430 (UMLS CUI [14,2])
C0679823 (UMLS CUI [14,3])
C0008976 (UMLS CUI [14,4])
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