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Genetic Variation in Platelet Aggregation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
C. Michael Stein, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01576536
First received: April 10, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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


Condition
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Variation in Platelet Aggregation

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • percentage platelet aggregation [ Time Frame: Within 120minutes of sample collection ] [ Designated as safety issue: No ]
    We will compare the percentage platelet aggregation to 2µM epinephrine between haplotype 4 family participants and other haplotype families


Secondary Outcome Measures:
  • Percentage platelet aggregation to collagen and ADP [ Time Frame: within 120 minutes of sample collection ] [ Designated as safety issue: No ]
    We will compare the percentage platelet aggregation to collagen and ADP between haplotype 4 participant and other haplotype families.

  • Percentage platelet aggregation after cold pressor test [ Time Frame: within 120 minutes of sample collection ] [ Designated as safety issue: No ]
    We will compare percentage platelet aggregation of different agonist after cold pressor test between haplotype 4 participants and other haplotype families.


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy volunteers
Normal healthy volunteers

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576536

Contacts
Contact: Michael C Stein, MBChB 615-936-3420 mike.stein@vanderbilt.edu
Contact: Abiodun O Adefurin, MBChB 901 857 2032 abiodun.o.adefurin@vanderbilt.edu

Locations
United States, Tennessee
the Vanderbilt University General Clinical Research Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Michael C Stein, MBChB    615-936-3420    mike.stein@vanderbilt.edu   
Contact: Abiodun Adefurin, MBChB    901 857 2032    abiodun.o.adefurin@vanderbilt.edu   
Principal Investigator: Michael Stein, MBChB         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Michael Stein, MBChB Vanderbilt University
  More Information

No publications provided

Responsible Party: C. Michael Stein, Dan May Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01576536     History of Changes
Other Study ID Numbers: 111760
Study First Received: April 10, 2012
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Myocardial infarction
Platelet aggregation
cold pressor test
Genetics

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014