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OpenTrials
Completed

NCT Number: NCT01576536

Genetic Variation in Platelet Aggregation

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Vanderbilt University General Clinical Research Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Percentage, Adenosine Diphosphate (ADP) Induced Platelet Aggregation

    Time frame: at 6am and 930am

    Blood samples were taken from participants and centrifuged. Adenosine Diphosphate (ADP) at a fixed concentration of 2.5 uM was added. Agonist-induced platelet aggregation was expressed as the percentage aggregation after 6 minutes of stimulation.

  2. Percentage, Collagen Induced Platelet Aggregation

    Time frame: at 6am and 930am

    Blood samples were taken from participants and centrifuged. Collagen at a fixed concentration of 2.5 ug/ml was added. Agonist-induced platelet aggregation was expressed as the percentage aggregation after 6 minutes of stimulation.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Apr 12, 2012
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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