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Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic

This study is currently recruiting participants.
Verified July 2017 by Mina Chung, The Cleveland Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921986
First Posted: June 17, 2009
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mina Chung, The Cleveland Clinic
  Purpose
Biorepository of blood and or tissue samples from patients presenting with cardiac arrhythmia syndromes.

Condition
Arrhythmias, Cardiac

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cleveland Clinic Arrhythmia Biospecimen Repository (Cleveland Clinic Arrhythmia BioBank)

Resource links provided by NLM:


Further study details as provided by Mina Chung, The Cleveland Clinic:

Primary Outcome Measures:
  • Genetic variants associated with arrhythmias [ Time Frame: Baseline ]
    Genome-wide association study of arrhythmias


Biospecimen Retention:   Samples With DNA
Biospecimens to be collected: DNA, RNA, plasma, & serum. Also tissue may be collected.

Estimated Enrollment: 2000
Actual Study Start Date: March 2009
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Arrhythmias
Patients with arrhythmias
Control Subjects
Subjects that do not have a history of cardiac arrhythmias.

Detailed Description:
The long-term objective of this research is to find genes and biologic pathways causing arrhythmia syndromes and other diseases or conditions. In order to achieve this objective the investigators will collect comprehensive phenotypic data and corresponding blood and/or tissue samples into a biorepository registry of patients, presenting for cardiac arrhythmia evaluation and/or treatment, and control subjects without arrhythmias. This biorepository will be composed of two parts: 1) An Arrhythmia Biorepository of blood and tissue from patients undergoing arrhythmia procedures, cardiac surgery, or inpatient or outpatient evaluations for arrhythmias, and 2) A Collaborative Sample Biorepository for de-identified samples and data from outside institutions and clinical trials.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing arrhythmia procedures, cardiac surgery or inpatient or outpatient evaluations for arrhythmias at the Cleveland Clinic or from outside collaborative institutions or from other clinical trials.
Criteria

Inclusion Criteria:

  • Male or female at least 18 years old
  • Subjects with a history of or current cardiac arrhythmia, family members of subjects with cardiac arrhythmias, or no cardiac arrhythmia if a Control Subject.

Exclusion Criteria:

  • Subjects previously enrolled in the Arrhythmia BioBank
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921986


Contacts
Contact: Mina K. Chung, MD 216.444.2290 chungm@ccf.org

Locations
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Mina K. Chung, MD         
Sub-Investigator: David R. Van Wagoner, Ph.D.         
Sub-Investigator: Jonathan D. Smith, Ph.D.         
Sub-Investigator: John Barnard, Ph.D.         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Mina K. Chung, MD The Cleveland Clinic
  More Information

Responsible Party: Mina Chung, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00921986     History of Changes
Other Study ID Numbers: 09-176
First Submitted: June 15, 2009
First Posted: June 17, 2009
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mina Chung, The Cleveland Clinic:
genetics
biorepository
cardiac death
atrial fibrillation
ventricular fibrillation
ventricular tachycardia
supraventricular tachycardias
premature ventricular complexes
premature atrial complexes
atrioventricular and intraventricular blocks
sinus node dysfunction
syncope
vasovagal reactivity
postural orthostatic tachycardia syndrome

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes