Cardiovascular DiseasesNCT00005265
Natural History of Coronary Heart Disease
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine the natural history of mortality due to coronary heart disease in post-myocardial infarction patients from the Beta-Blocker Heart Attack Trial (BHAT) and the Aspirin Myocardial Infarction Study (AMIS). Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1990to May 1992
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To examine the natural history of mortality due to coronary heart disease in post-myocardial infarction patients from the Beta-Blocker Heart Attack Trial (BHAT) and the Aspirin Myocardial Infarction Study (AMIS).
Read the detailed description
BACKGROUND:
In January 1990, the National Heart, Lung, and Blood Institute issued a Program Announcement establishing a Small Grants Program to provide limited support to extend analyses of research data generated by clinical trials, population research, and demonstration and education studies. This study used data collected in two completed clinical trials, the BHAT and AMIS.
DESIGN NARRATIVE:
Study endpoints included all-cause mortality, cause-specific mortality such as sudden death, recurrent and non-fatal myocardial infarction, and incident congestive heart failure. Univariate and multivariate analyses of baseline data variables from BHAT were conducted to determine which were predictive of study endpoints. Baseline variables included sociodemograhic characteristics, medical history, medication use, physical examination finds, and electrocardiographic characteristics. Baseline characteristics found to be predictive of study endpoints in the BHAT placebo group were examined in the AMIS placebo group. Long- and short-term prognoses for patients suffering a transmural myocardial infarction were compared for those suffering a subendocardial infarction.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction, Heart Diseases, Death, Sudden, Cardiac, Heart Failure, Congestive
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction, Heart Diseases, Death, Sudden, Cardiac, Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1990
- Study completionMay 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005265
- Sponsor's protocol ID
- 1149
- Other IDs
- R03HL045495
- Status last verified
- Nov 2001
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00005265
- Acronym / sponsor ID
- 1149
- Conditions
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction, Heart Diseases, Death, Sudden, Cardiac, Heart Failure, Congestive
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1990
- Study completion
- May 1992 (actual)
- First posted
- 26 May 2000 (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.
To examine the natural history of mortality due to coronary heart disease in post-myocardial infarction patients from the Beta-Blocker Heart Attack Trial (BHAT) and the Aspirin Myocardial Infarction Study (AMIS).
Detailed description
BACKGROUND:
In January 1990, the National Heart, Lung, and Blood Institute issued a Program Announcement establishing a Small Grants Program to provide limited support to extend analyses of research data generated by clinical trials, population research, and demonstration and education studies. This study used data collected in two completed clinical trials, the BHAT and AMIS.
DESIGN NARRATIVE:
Study endpoints included all-cause mortality, cause-specific mortality such as sudden death, recurrent and non-fatal myocardial infarction, and incident congestive heart failure. Univariate and multivariate analyses of baseline data variables from BHAT were conducted to determine which were predictive of study endpoints. Baseline variables included sociodemograhic characteristics, medical history, medication use, physical examination finds, and electrocardiographic characteristics. Baseline characteristics found to be predictive of study endpoints in the BHAT placebo group were examined in the AMIS placebo group. Long- and short-term prognoses for patients suffering a transmural myocardial infarction were compared for those suffering a subendocardial infarction.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 13 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 13 May 2016.