Cardiovascular DiseasesNCT00005460
Predictors of Cardiovascular Disease in the Elderly
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To evaluate factors associated with cardiovascular morbidity and mortality in a cohort of 795 men and women aged 75 years or older at the time of a comprehensive examination conducted between 1984 and 1987. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1991to Dec 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 evaluate factors associated with cardiovascular morbidity and mortality in a cohort of 795 men and women aged 75 years or older at the time of a comprehensive examination conducted between 1984 and 1987.
Read the detailed description
BACKGROUND:
The study was needed because evidence in 1991 suggested that cardiovascular risk factors which had been identified by studies of middle-aged populations did not have the same predictive value in the elderly; especially the "oldest old" aged 75 and above.
DESIGN NARRATIVE:
The study analyzed data that had been collected over the years. At the time of the analysis, mortality follow-up was complete for over 99 percent of subjects, and incident morbidity information was available for myocardial infarction, coronary bypass surgery and stroke. The database included measurements which allowed: 1) prospective analyses of the effects of putative cardiovascular risk factors on disease incidence in the elderly, 2) prospective analyses of the impact of change in risk factors on events in the elderly, 3) exploration of risk factors not classically associated with cardiovascular events in younger populations but which may be important in the very old, and, 4) cross-sectional description of putative risk factors in an aged population.
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, Heart Diseases, Myocardial Infarction, Cerebrovascular Accident, Coronary Disease, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Stroke, Coronary Disease, Hypertension
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 startJan 1991
- Study completionDec 1992
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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005460
- Sponsor's protocol ID
- 4904
- Other IDs
- R01HL044689
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Langer RD, Criqui MH, Barrett-Connor EL, Klauber MR, Ganiats TG. Blood pressure change and survival after age 75. Hypertension. 1993 Oct;22(4):551-9. doi: 10.1161/01.hyp.22.4.551.
PubMed 8406660
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Cardiovascular Disease in the Elderly
- ClinicalTrials.gov ID
- NCT00005460
- Acronym / sponsor ID
- 4904
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Cerebrovascular Accident, Coronary Disease, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1991
- Study completion
- Dec 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 evaluate factors associated with cardiovascular morbidity and mortality in a cohort of 795 men and women aged 75 years or older at the time of a comprehensive examination conducted between 1984 and 1987.
Detailed description
BACKGROUND:
The study was needed because evidence in 1991 suggested that cardiovascular risk factors which had been identified by studies of middle-aged populations did not have the same predictive value in the elderly; especially the "oldest old" aged 75 and above.
DESIGN NARRATIVE:
The study analyzed data that had been collected over the years. At the time of the analysis, mortality follow-up was complete for over 99 percent of subjects, and incident morbidity information was available for myocardial infarction, coronary bypass surgery and stroke. The database included measurements which allowed: 1) prospective analyses of the effects of putative cardiovascular risk factors on disease incidence in the elderly, 2) prospective analyses of the impact of change in risk factors on events in the elderly, 3) exploration of risk factors not classically associated with cardiovascular events in younger populations but which may be important in the very old, and, 4) cross-sectional description of putative risk factors in an aged population.
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 29 Feb 2016.
- Background: PubMed 8406660Langer RD, Criqui MH, Barrett-Connor EL, Klauber MR, Ganiats TG. Blood pressure change and survival after age 75. Hypertension. 1993 Oct;22(4):551-9. doi: 10.1161/01.hyp.22.4.551.
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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 Heart Diseases, 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 29 Feb 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?
On the ClinicalTrials.gov record for NCT00005460, 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 29 Feb 2016.