Genetic Variation in Platelet Aggregation

NCT ID: NCT01576536

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 117 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-12-31

Brief Summary

The aim of the study is to test whether genetic variation in the alpha 2A adrenergic receptor affects diurnal variation in platelet aggregation.

Detailed Description

There is a marked diurnal fluctuation in the occurrence of acute myocardial infarction and sudden death, with peak incidences occurring in the early morning. Platelet aggregation has also been shown to increase in the early morning. The investigators will test the hypothesis that alpha 2a-adrenergic receptor (ADRA2A) genetic variation, specifically haplotype 4, affects platelet aggregation. The investigators will compare diurnal platelet aggregation in haplotype 4 subjects with subjects in the other haplotype families. In addition, the investigators will compare platelet aggregation after the cold pressor test in haplotype 4 with the other haplotype families. If there are no differences among haplotypes, then the haplotypes will be combined to analyze.

Conditions

Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers

Normal healthy volunteers

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Men and women aged 18 - 45 years inclusive.
• Women of the above age will be studied between day 1 and day 14 of a normal menstrual cycle.
• Subjects must be willing to give informed consent for the study and able to adhere to the study diet and study procedures.
• Subjects and immediate extended family up till grandparents will be Caucasians or African Americans only.
• Subjects will be free of any clinically significant disease.
• Clinical laboratory test (CBC, blood chemistry) will be within acceptable limits.

Exclusion Criteria

• Subjects who have taken any antiplatelet, anticoagulant or procoagulant medicines within the last three weeks preceding the study.
• Subjects who have taken medications (including over the counter medications) other than oral contraceptives in the past two weeks.
• Subjects who smoke or have smoked in the past 3 months.
• Subjects who are presently or were formerly a narcotic addict or alcoholic.
• Females with a positive pregnancy test.
• Females who are breast feeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

C. Michael Stein

Dan May Professor of Medicine and Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Stein, MBChB

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

the Vanderbilt University General Clinical Research Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

111760

Identifier Type: -

Identifier Source: org_study_id