Genetic Variation in Platelet Aggregation

NCT01576536 | Completed Results

• 1 other identifier: 111760
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Myocardial infarction; Platelet aggregation; cold pressor test; Genetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage, Adenosine Diphosphate (ADP) Induced Platelet Aggregation

  at 6am and 930am

• Percentage, Collagen Induced Platelet Aggregation

  at 6am and 930am

Study Arms (1)

Healthy volunteers

Normal healthy volunteers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects will be recruited by advertisement and word-of-mouth.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

the Vanderbilt University General Clinical Research Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for DNA and plasma/serum for subsequent biomarker analysis if required.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Limitations and Caveats

Healthy young subjects studied, thus findings may not apply to different populations. Plasma catecholamines are an indirect measure of sympathetic activity--norepinephrine spillover would be more precise, but is technically demanding, not feasible.

Results Point of Contact

• Title: Dr. C. M. Stein
• Organization: Vanderbilt University Medical Center

mike.stein@vanderbilt.edu

615-936-3420

Study Officials

• Michael Stein, MBChB

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dan May Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: June 5, 2019
• Results First Posted: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication
• Access Criteria: Access Criteria: IPD will be shared on request made to the PI. Criteria: Data is not to be shared. Data should only be used for biomedical research. Researchers requesting access will need appropriate IRB approval and sign a data use agreement.

Locations

US (1)