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Clinical Trials/NCT01576536
NCT01576536
Completed
Not Applicable

Genetic Variation in Platelet Aggregation

Vanderbilt University1 site in 1 country117 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Infarction
Sponsor
Vanderbilt University
Enrollment
117
Locations
1
Primary Endpoint
LogEC50 Platelet Aggregation
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
December 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

C. Michael Stein

Dan May Professor of Medicine and Pharmacology

Vanderbilt University

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.

Outcomes

Primary Outcomes

LogEC50 Platelet Aggregation

Time Frame: at 6am and 930am

EC50 represents the epinephrine concentration that produced 50% of maximal platelet aggregation (representing sensitivity to epinephrine) EC50 values were not normally distributed and were log-transformed for analyses.

Secondary Outcomes

  • Percentage, Adenosine Diphosphate (ADP) Induced Platelet Aggregation(at 6am and 930am)
  • Percentage, Collagen Induced Platelet Aggregation(at 6am and 930am)

Study Sites (1)

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