Cardiology Biobank Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Arshed A. Quyyumi, Emory University
ClinicalTrials.gov Identifier:
NCT00378924
First received: September 19, 2006
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

Statement of the Problem:

Over the last several decades, scientists have made great progress in their understanding of cardiovascular disease. Nevertheless, much remains to be learned about the causes, course, and treatment of cardiovascular disease. In order to learn more about this topic, it is important to establish large databases of cardiovascular patients. These databases allows scientists to investigate, in a rigorous and precise manner, those factors that influence cardiovascular disease.

How the Problem Will Be Studied:

In the present study, we intend to establish a large database of cardiovascular patients. More specifically, we will create a database of approximately 12,000 cardiac catheterization and heart failure patients from Emory University Hospital, the Emory Clinic, Crawford Long Hospital, and Grady Memorial Hospital.

We will collect a large amount of data on these patients. Data to be collected will include information on:

  1. medical history of the patient
  2. medical history of the patient's family
  3. health behaviors of the patient
  4. psychological status of the patient
  5. results of procedures the patient undergoes, such as catheterization/angioplasty/bypass
  6. biochemical markers in patient blood samples, including genetic/DNA markers
  7. follow-up information on patient outcomes such as mortality or re-hospitalization

The data noted above will be collected by:

  1. administering questionnaires/interviews to the patients
  2. accessing the medical records of the patients
  3. collecting blood samples from patients which will be analyzed by laboratories for their biochemical content.

Once the data has been collected, we will run a variety of statistical analyses to which will help us to learn more about the factors that cause various cardiovascular diseases such as coronary heart disease, angina, heart failure, hypertension, and stroke. The statistical analyses will also help us to understand how these diseases can be treated more effectively.

How the Research Will Advance Scientific Knowledge/Human Health:

By collecting a large amount of data on a large number of cardiovascular patients, we will be able to analyze, with a great deal of precision, those factors that influence the onset, course, and treatment of cardiovascular disease. The results of these precise analyses can then be used to help optimize clinical efforts to prevent and treat cardiovascular disease.


Condition Phase
Cardiovascular Disease
Phase 1

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Cardiology Biobank Registry

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • All cause death [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular death [ Time Frame: Continuous ] [ Designated as safety issue: No ]
  • Re-hospitalization for heart failure [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Myocardial Infarction [ Time Frame: Continuous ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

60 cc of blood will be obtained from the participant. Blood will be processed and stored in -80F freezers as plasma, serum, extracted DNA and whole blood.


Estimated Enrollment: 12000
Study Start Date: December 2003
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

General population & patients presenting to the hospital

Criteria

Inclusion Criteria:

  • 18 & Older

Exclusion Criteria:

  • Congenital Heart Disease
  • Recent Blood Transfusion (less than a month)
  • Moderate to Severe Anemia
  • Active cancer
  • Physician request for patient not to be included in study
  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: NCT00378924

Contacts
Contact: Danny J Eapen, MD 404 712 0168 deapen@emory.edu
Contact: Salman Sher, MD 404 412 0170 ssher2@emory.edu

Locations
United States, Georgia
Emory School Of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Danny J Eapen, MD    404-712-0168    deapen@emory.edu   
Contact: Salman Sher, MD    404 712 0170    ssher2@emory.edu   
Principal Investigator: Arshed A Quyyumi, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Arshed A Quyyumi, MD Emory School Of Medicine
  More Information

No publications provided

Responsible Party: Arshed A. Quyyumi, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00378924     History of Changes
Other Study ID Numbers: IRB00000343, 950-2003
Study First Received: September 19, 2006
Last Updated: May 15, 2014
Health Authority: United States: Emory University IRB

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014