Cardiovascular DiseasesCARDIA ECGNCT00556751
Evaluating Electrocardiogram (ECG) Abnormalities From Young Adulthood Through Middle Age
An observational study of Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 5,115 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1985to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Participated in the CARDIA study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology and Mechanisms of ECG Abnormalities: Young Adulthood to Middle Age
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Keywords
- Electrocardiogram, Electrocardiography, Cardiovascular Risk Factors, Cholesterol, Blood Pressure, Diabetes
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of resting ECG abnormalities, specifically isolated non-specific ST-segment and T-wave abnormalities
Measured: Measured at Years 7 and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startJan 1985
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,115 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Donald M. Lloyd-Jones, MD, ScM, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556751
- Sponsor's protocol ID
- 1406
- Other IDs
- R01HL086792
- Acronym
- CARDIA ECG
- Status last verified
- Dec 2007
- First submitted
- 8 Nov 2007
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1016/0197-2456(91)90002-4. No abstract available.
PubMed 1851696
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Mechanisms of ECG Abnormalities: Young Adulthood to Middle Age
- ClinicalTrials.gov ID
- NCT00556751
- Acronym / sponsor ID
- CARDIA ECG / 1406
- Conditions
- Cardiovascular Diseases
- Keywords
- Electrocardiogram, Electrocardiography, Cardiovascular Risk Factors, Cholesterol, Blood Pressure, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,115 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1985
- Study completion
- Sep 2006 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Participated in the CARDIA study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of resting ECG abnormalities, specifically isolated non-specific ST-segment and T-wave abnormalities
Time frame: Measured at Years 7 and 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 1851696Cutter 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. doi: 10.1016/0197-2456(91)90002-4. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald M. Lloyd-Jones, MD, ScM principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of resting ECG abnormalities, specifically isolated non-specific ST-segment and T-wave abnormalities (time frame: Measured at Years 7 and 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00556751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.