Evaluating Electrocardiogram (ECG) Abnormalities From Young Adulthood Through Middle Age (CARDIA ECG)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00556751
First received: November 8, 2007
Last updated: December 12, 2007
Last verified: December 2007
  Purpose

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.


Condition
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Epidemiology and Mechanisms of ECG Abnormalities: Young Adulthood to Middle Age

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Development of resting ECG abnormalities, specifically isolated non-specific ST-segment and T-wave abnormalities [ Time Frame: Measured at Years 7 and 20 ]

Enrollment: 5115
Study Start Date: January 1985
Study Completion Date: September 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

CARDIA study participants, which included black and white men and women, 18- to 30-years-old at the time of study entry from 1985 to 1986, and balanced on sex, race, and education status

Criteria

Inclusion Criteria:

  • Participated in the CARDIA 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: NCT00556751

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Investigators
Principal Investigator: Donald M. Lloyd-Jones, MD, ScM Northwestern University Feinberg School of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00556751     History of Changes
Other Study ID Numbers: 1406, R01 HL086792
Study First Received: November 8, 2007
Last Updated: December 12, 2007
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Electrocardiogram
Electrocardiography
Cardiovascular Risk Factors
Cholesterol
Blood Pressure
Diabetes

Additional relevant MeSH terms:
Congenital Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014