Genetic Variation in Platelet Aggregation

Myocardial Infarction Clinical Trial

Official title:

Genetic Variation in Platelet Aggregation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576536
• Other study ID #: 111760
• Status: Completed
• Start date: July 2012
• Est. completion date: December 2016

Study information

• Verified date: June 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	the Vanderbilt University General Clinical Research Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LogEC50 Platelet Aggregation	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.	at 6am and 930am
Secondary	Percentage, Adenosine Diphosphate (ADP) Induced Platelet Aggregation	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.	at 6am and 930am
Secondary	Percentage, Collagen Induced Platelet Aggregation	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.	at 6am and 930am