Cardiovascular DiseasesNCT00005162
Epidemiology of Decline in Heart Disease Mortality
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To continue a study of premature coronary heart disease mortality among men and women aged 35-54 in Allegheny County, Pennsylvania. 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, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1983to Nov 1996
- 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 continue a study of premature coronary heart disease mortality among men and women aged 35-54 in Allegheny County, Pennsylvania.
Read the detailed description
BACKGROUND:
The decline in coronary heart disease mortality apparently began around 1963 in the United States and increased in intensity in later years. In the 35-44 age groups the decline began somewhat later, perhaps around 1968. The decline has been found in all four race sex groups and in all age groups including the very old. This decline has also been noted in many other countries besides the United States. The decline of coronary heart disease mortality could obviously be a function of either a change in incidence or in case fatality or both. During the time of this decline in coronary heart disease mortality a great many changes were occurring both in the care of the cardiac patients and changes in risk factors. The fact that the decline occurred across all age as well as race, and sex groups as well as in many other countries suggested that one single factor may not have accounted for the decline.
It was very unlikely that the decline of sudden death was due to improved out-of-hospital care or an early recognition of symptoms. The three percent per year decline suggested that acute precipitating factors other than the underlying atherosclerosis were the most likely factors to account for the decline, especially in the younger age groups of men.
The study was designed to evaluate whether the decrease in coronary heart disease mortality was real or due to an artifact of certification practices or accuracy of diagnosis. The design was based on the fact that the best opportunity to study the decline was in the 35-44 age group.
DESIGN NARRATIVE:
A retrospective review was made of all death certificates certified to coronary heart disease, all other cardiovascular deaths, and all non-traumatic but possibly sudden deaths certified by the coroner. The review included autopsy records, coroner's reports, hospital records, information from certifying physicians, and interviews with next-of-kin or witnesses. A determination was made of the contribution to the decline of out-of-hospital sudden death and prior history of heart disease, other diseases, and possibly cigarette smoking. The changing mode of death for in-hospital deaths was also evaluated.
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, Coronary Disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
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 startAug 1983
- Study completionNov 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- NCT00005162
- Sponsor's protocol ID
- 1034
- Other IDs
- R37HL030793
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Traven ND, Kuller LH, Ives DG, Rutan GH, Perper JA. Coronary heart disease mortality and sudden death among the 35-44-year age group in Allegheny County, Pennsylvania. Ann Epidemiol. 1996 Mar;6(2):130-6. doi: 10.1016/1047-2797(95)00131-x.
PubMed 8775593Kuller LH, Perper JA, Dai WS, Rutan G, Traven N. Sudden death and the decline in coronary heart disease mortality. J Chronic Dis. 1986;39(12):1001-19. doi: 10.1016/0021-9681(86)90136-0. No abstract available.
PubMed 3539964Kuller LH: Controlling Coronary Heart Disease: Where We Will Stand by the End of This Decade. Perspect Lipid Disorders, 4:10-16, 1986
Kuller LH, Traven ND, Rutan GH, Perper JA, Ives DG. Marked decline of coronary heart disease mortality in 35-44-year-old white men in Allegheny County, Pennsylvania. Circulation. 1989 Aug;80(2):261-6. doi: 10.1161/01.cir.80.2.261.
PubMed 2752556Traven ND, Kuller LH, Ives DG, Rutan GH, Perper JA. Coronary heart disease mortality and sudden death: trends and patterns in 35- to 44-year-old white males, 1970-1990. Am J Epidemiol. 1995 Jul 1;142(1):45-52. doi: 10.1093/oxfordjournals.aje.a117544.
PubMed 7785673
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
- Epidemiology of Decline in Heart Disease Mortality
- ClinicalTrials.gov ID
- NCT00005162
- Acronym / sponsor ID
- 1034
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1983
- Study completion
- Nov 1996 (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 continue a study of premature coronary heart disease mortality among men and women aged 35-54 in Allegheny County, Pennsylvania.
Detailed description
BACKGROUND:
The decline in coronary heart disease mortality apparently began around 1963 in the United States and increased in intensity in later years. In the 35-44 age groups the decline began somewhat later, perhaps around 1968. The decline has been found in all four race sex groups and in all age groups including the very old. This decline has also been noted in many other countries besides the United States. The decline of coronary heart disease mortality could obviously be a function of either a change in incidence or in case fatality or both. During the time of this decline in coronary heart disease mortality a great many changes were occurring both in the care of the cardiac patients and changes in risk factors. The fact that the decline occurred across all age as well as race, and sex groups as well as in many other countries suggested that one single factor may not have accounted for the decline.
It was very unlikely that the decline of sudden death was due to improved out-of-hospital care or an early recognition of symptoms. The three percent per year decline suggested that acute precipitating factors other than the underlying atherosclerosis were the most likely factors to account for the decline, especially in the younger age groups of men.
The study was designed to evaluate whether the decrease in coronary heart disease mortality was real or due to an artifact of certification practices or accuracy of diagnosis. The design was based on the fact that the best opportunity to study the decline was in the 35-44 age group.
DESIGN NARRATIVE:
A retrospective review was made of all death certificates certified to coronary heart disease, all other cardiovascular deaths, and all non-traumatic but possibly sudden deaths certified by the coroner. The review included autopsy records, coroner's reports, hospital records, information from certifying physicians, and interviews with next-of-kin or witnesses. A determination was made of the contribution to the decline of out-of-hospital sudden death and prior history of heart disease, other diseases, and possibly cigarette smoking. The changing mode of death for in-hospital deaths was also evaluated.
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.
- Background: PubMed 8775593Traven ND, Kuller LH, Ives DG, Rutan GH, Perper JA. Coronary heart disease mortality and sudden death among the 35-44-year age group in Allegheny County, Pennsylvania. Ann Epidemiol. 1996 Mar;6(2):130-6. doi: 10.1016/1047-2797(95)00131-x.
- Background: PubMed 3539964Kuller LH, Perper JA, Dai WS, Rutan G, Traven N. Sudden death and the decline in coronary heart disease mortality. J Chronic Dis. 1986;39(12):1001-19. doi: 10.1016/0021-9681(86)90136-0. No abstract available.
- BackgroundKuller LH: Controlling Coronary Heart Disease: Where We Will Stand by the End of This Decade. Perspect Lipid Disorders, 4:10-16, 1986
- Background: PubMed 2752556Kuller LH, Traven ND, Rutan GH, Perper JA, Ives DG. Marked decline of coronary heart disease mortality in 35-44-year-old white men in Allegheny County, Pennsylvania. Circulation. 1989 Aug;80(2):261-6. doi: 10.1161/01.cir.80.2.261.
- Background: PubMed 7785673Traven ND, Kuller LH, Ives DG, Rutan GH, Perper JA. Coronary heart disease mortality and sudden death: trends and patterns in 35- to 44-year-old white males, 1970-1990. Am J Epidemiol. 1995 Jul 1;142(1):45-52. doi: 10.1093/oxfordjournals.aje.a117544.
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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 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?
On the ClinicalTrials.gov record for NCT00005162, which also lists 5 linked publications.
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.