An electrocardiogram (ECG) is a test that evaluates the electrical activity of the heart and can be used to detect heart problems. By analyzing ECGs collected over a 20-year period, this study will examine ECG abnormalities and the differences in ECG findings between black and white people, from young adulthood through middle age...
Date First Received: November 8, 2007
Last Updated: December 12, 2007
Verified by: National Heart, Lung, and Blood Institute (NHLBI), December 2007
Clinical Trial Phase: N/A | Start Date: January 1985
Overall Status: Completed
Estimated Enrollment: 5115
Brief Summary
Official Title: “Epidemiology and Mechanisms of ECG Abnormalities: Young Adulthood to Middle Age”
Condition Keyword(s):
An electrocardiogram (ECG) is a test that evaluates the electrical activity of the heart and can be used to detect heart problems. By analyzing ECGs collected over a 20-year period, this study will examine ECG abnormalities and the differences in ECG findings between black and white people, from young adulthood through middle age.
Study Type: Observational
Study Design: Cohort, Retrospective
Detailed Clinical Trial Description
An ECG is a test that detects and records the electrical activity of the heart. As a diagnostic tool, it can detect and locate the source of heart problems, including heart attacks, irregular heart beats, cardiovascular disease, or other abnormalities of the heart.
An ECG procedure involves attaching electrodes to the skin on the chest, arms, and legs while the electrodes detect electrical signals of the heart, and a machine displays the signals on a computer screen and graph paper. An ECG may be a beneficial way to detect cardiovascular disease because it is a low-cost and non-invasive test that is widely available in the clinical setting.
This study will examine ECGs and other study data from participants in the Coronary Artery Risk Development in Young Adults (CARDIA) study. As ECG abnormalities typically begin to develop in young adults, the CARDIA participants will provide researchers with an excellent study population. As part of the CARDIA study, ECGs were obtained from participants at baseline, and Years 7 and 20. Study researchers will use state-of-the-art technology and standardized Minnesota Code and Novacode methods to electronically code participants' ECGs and accomplish the following: 1) assess the frequency of ECG abnormalities in young adults of different races; 2) examine potential risk factors for the development and progression of ECG abnormalities; 3) investigate the relationship between ECG abnormalities and other measures of heart disease; and 4) assess differences in the frequency and patterns of ECG abnormalities between different racial groups. Study researchers will also analyze additional CARDIA study data, including cardiovascular disease risk factors, measures of atherosclerosis, and echocardiographic ultrasound pictures of the heart.
This research will provide important insights into the ways in which ECG abnormalities are associated with increased risk for cardiovascular disease and how the risk may differ between blacks and whites. Results from this study may ultimately lead to improvements in preventive strategies for cardiovascular disease in young adults.
Outcome Measures for this Clinical Trial
Primary Measures
- Development of resting ECG abnormalities, specifically isolated non-specific ST-segment and T-wave abnormalities
- Time Frame: Measured at Years 7 and 20
- Time Frame: Measured at Years 7 and 20
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Participated in the CARDIA study
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Overall Clinical Trial Officials and Contacts
Donald M. Lloyd-Jones, MD, ScM Principal Investigator Northwestern University Feinberg School of Medicine
Related Publications
References
Cutter GR, Burke GL, Dyer AR, Friedman GD, Hilner JE, Hughes GH, Hulley SB, Jacobs DR Jr, Liu K, Manolio TA, et al. Cardiovascular risk factors in young adults. The CARDIA baseline monograph. Control Clin Trials. 1991 Feb;12(1 Suppl):1S-77S. No abstract available.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00556751
Study ID Number: 1406
ClinicalTrials.gov Identifier: NCT00556751
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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