Cardiovascular DiseasesNCT00005148
Coronary Heart Disease Incidence, Mortality, and Risk Factor Relationships
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the incidence, secular trends, and outcomes of coronary heart disease in the population of Rochester, Minnesota. 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, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1979to Aug 1991
- 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 determine the incidence, secular trends, and outcomes of coronary heart disease in the population of Rochester, Minnesota.
Read the detailed description
BACKGROUND:
Many factors may have contributed to the decline in coronary heart disease including revised coding of death certificates, behavioral modification of risk factors, improvements in emergency and other hospital care, and use of new medications and surgery. The Rochester Heart Study contributed trend data covering the time before and during the decline in coronary heart disease mortality. At that time, medical care for residents of Rochester and Olmsted County was almost exclusively provided by the Mayo Clinic and Olmsted Medical Group. Under the Rochester Epidemiology Program Project supported by program project grants from the National Institute of General Medical Sciences and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the medical records of the Olmsted Medical Group and Community Hospital were indexed for retrieval by the same system as the Mayo Clinic. Those of other outside sources such as the University of Minnesota Hospital, Rochester State Hospital, and Veterans Hospitals which pertained to the occasional admission of Olmsted County residents were also added to the Mayo Clinic maintained diagnostic index. The resulting central diagnostic file gave virtually complete case assignments for diagnosed cases of myocardial infarction, sudden unexpected death, angina pectoris, and noncoronary heart disease.
DESIGN NARRATIVE:
The centralized case index of the Mayo Clinic and the Rochester Epidemiology Program Project were used to identify any Rochester resident with a diagnosis between 1950 and 1987 of any condition suggesting that coronary heart disease might be present. Included were diagnoses of coronary heart disease, myocardial infarction, angina pectoris, coronary insufficiency, or arrhythmias. All relevant index codes were specified and a computer generated list was provided of the unit record numbers of all candidate cases. The medical histories were then retrieved and reviewed for inclusion. The screened histories were assigned to nurse abstractors whose duty it was to identify from the screening list those patients who satisfied the diagnostic criteria in the protocol as well as the incidence and residence requirements. In case finding of coronary heart disease incidence, the following had to be true: the diagnosis of angina pectoris, myocardial infarction or sudden unexpected death must have satisfied the protocol's diagnostic criteria; the diagnosis must have been a first diagnosis; the patient, at the time of first diagnosis, must have been free of diagnoses of congestive heart failure and valvular heart disease; the patient must have been a resident of Rochester at the time of diagnosis. If all of these criteria were met, the electrocardiograms were read by a physician for case verification. A precoded abstract of the history was prepared for each incidence case. The abstract included: identification and demographic data; information on smoking, hypertension, hypertension therapy, lipids, and use of estrogens; diagnostic factors such as ECG, treatment tests, angiography, and selected laboratory test results. The first myocardial infarction following the first coronary heart disease diagnosis was coded; if the first manifestation of coronary heart disease was a myocardial infarction, the second myocardial infarction was coded to provide a basis for determining reinfarction rates. In the earlier study done from 1950-1969, little data on treatment were abstracted. From 1970 to 1991t, drugs and surgery were abstracted. All death certificates for Rochester and Olmsted County residents for the period 1960-1979 were recoded to the 8th revision of the ICDA in order to obtain comparability over the study period. All deaths suspected of being due to some form of coronary heart disease were reviewed by a group of cardiologists using a clinical classification of death. The cardiologists used medical, hospital, and autopsy records to determine cause of death. Follow up was 99 percent complete. Date of last follow-up and cause of death were recorded.
The medical records for all Olmsted County residents ages 30 and over coming to autopsy for the period 1950-1978 were reviewed. Data abstracted included date of death, age at death, sex, weight, heart weight, grade of lesions in the coronary arteries, and evidence of recent or old myocardial infarction. All autopsy records for 1980 through 1984 were reviewed for coronary heart disease. Beginning in 1986, valvular heart disease data were also collected for the period 1950 through 1987.
The effect of the Diagnostic Related Groups (DRG) on incidence rates for coronary and valvular heart disease was ascertained for all cases hospitalized after January 1, 1984. The Mayo Medical Center DRG system which captured and retained diagnoses on hospitalized patients was compared with the study medical index files.
Incident cases were also followed for specific diagnostic and therapeutic procedures. This was accomplished by record review and by matching lists of case patient numbers with identification numbers of patients who underwent the following: radionuclide ejection fractions and radionuclide exercise tests beginning in 1980; arteriography, ventriculography, valve evaluation, thrombolytic infusion, percutaneous transluminal coronary angioplasty or balloon angioplasty, and electrophysiologic testing beginning in 1976; coronary artery bypass surgery, myocardial resection, and valve repair or replacement beginning in 1978; coronary intensive care unit data beginning in 1976. New procedures were monitored as they came into use.
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, Heart Diseases, Myocardial Infarction, Angina Pectoris
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Angina Pectoris
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 1979
- Study completionAug 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)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
- NCT00005148
- Sponsor's protocol ID
- 1019
- Other IDs
- R01HL024326
- Status last verified
- Apr 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Connolly DC, Oxman HA, Nobrega FT, Kurland LT, Kennedy MA, Elveback LR. Coronary heart disease in residents of Rochester, Minnesota, 1950-1975. I. Background and study design. Mayo Clin Proc. 1981 Nov;56(11):661-4.
PubMed 7300444Elveback LR, Connolly DC, Kurland LT. Coronary heart disease in residents of Rochester, Minnesota. II. Mortality, incidence, and survivorship, 1950-1975. Mayo Clin Proc. 1981 Nov;56(11):665-72.
PubMed 7300445Beard CM, Fuster V, Elveback LR. Daily and seasonal variation in sudden cardiac death, Rochester, Minnesota, 1950-1975. Mayo Clin Proc. 1982 Nov;57(11):704-6.
PubMed 7132431Connolly DC, Elveback LR, Oxman HA. Coronary heart disease in residents of Rochester, Minnesota, 1950-1975. III. Effect of hypertension and its treatment on survival of patients with coronary artery disease. Mayo Clin Proc. 1983 Apr;58(4):249-54.
PubMed 6834892Connolly DC, Elveback LR, Oxman HA. Coronary heart disease in residents of Rochester, Minnesota. IV. Prognostic value of the resting electrocardiogram at the time of initial diagnosis of angina pectoris. Mayo Clin Proc. 1984 Apr;59(4):247-50. doi: 10.1016/s0025-6196(12)61257-9.
PubMed 6708602Garraway WM, Elveback LR, Connolly DC, Whisnant JP. The dichotomy of myocardial and cerebral infarction. Lancet. 1983 Dec 10;2(8363):1332-5. doi: 10.1016/s0140-6736(83)91091-7.
PubMed 6139670Beard CM, Fuster V, Annegers JF. Reproductive history in women with coronary heart disease. A case-control study. Am J Epidemiol. 1984 Jul;120(1):108-14. doi: 10.1093/oxfordjournals.aje.a113859.
PubMed 6741912Elveback LR, Connolly DC. Coronary heart disease in residents of Rochester, Minnesota. V. Prognosis of patients with coronary heart disease based on initial manifestation. Mayo Clin Proc. 1985 May;60(5):305-11. doi: 10.1016/s0025-6196(12)60537-0.
PubMed 3990378Connolly DC, Elveback LR. Coronary heart disease in residents of Rochester, Minnesota. VI. Hospital and posthospital course of patients with transmural and subendocardial myocardial infarction. Mayo Clin Proc. 1985 Jun;60(6):375-81. doi: 10.1016/s0025-6196(12)60846-5.
PubMed 3999808Elveback LR, Connolly DC, Melton LJ 3rd. Coronary heart disease in residents of Rochester, Minnesota. VII. Incidence, 1950 through 1982. Mayo Clin Proc. 1986 Nov;61(11):896-900. doi: 10.1016/s0025-6196(12)62612-3.
PubMed 3762228Kottke TE, Gatewood LC, Park HA. Using serum cholesterol to identify high risk and stimulate behavior change: will it work? Ann Med. 1989 Jun;21(3):181-7. doi: 10.3109/07853898909149930.
PubMed 2765259Beard CM, Kottke TE, Annegers JF, Ballard DJ. The Rochester Coronary Heart Disease Project: effect of cigarette smoking, hypertension, diabetes, and steroidal estrogen use on coronary heart disease among 40- to 59-year-old women, 1960 through 1982. Mayo Clin Proc. 1989 Dec;64(12):1471-80. doi: 10.1016/s0025-6196(12)65702-4.
PubMed 2557493Kottke TE. Clinical preventive services: how should we define the indications? Mayo Clin Proc. 1990 Jun;65(6):899-902. doi: 10.1016/s0025-6196(12)62582-8. No abstract available.
PubMed 2366590Kottke TE, Solberg LI, Brekke ML. Initiation and maintenance of patient behavioral change: what is the role of the physician? J Gen Intern Med. 1990 Sep-Oct;5(5 Suppl):S62-7. doi: 10.1007/BF02600845.
PubMed 2231068Kottke TE, Brekke ML. Cholesterol policy: what should we do? How should we decide? J Clin Epidemiol. 1990;43(10):1023-7. doi: 10.1016/0895-4356(90)90147-h. No abstract available.
PubMed 2213067
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
- Coronary Heart Disease Incidence, Mortality, and Risk Factor Relationships
- ClinicalTrials.gov ID
- NCT00005148
- Acronym / sponsor ID
- 1019
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Angina Pectoris
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1979
- Study completion
- Aug 1991 (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 determine the incidence, secular trends, and outcomes of coronary heart disease in the population of Rochester, Minnesota.
Detailed description
BACKGROUND:
Many factors may have contributed to the decline in coronary heart disease including revised coding of death certificates, behavioral modification of risk factors, improvements in emergency and other hospital care, and use of new medications and surgery. The Rochester Heart Study contributed trend data covering the time before and during the decline in coronary heart disease mortality. At that time, medical care for residents of Rochester and Olmsted County was almost exclusively provided by the Mayo Clinic and Olmsted Medical Group. Under the Rochester Epidemiology Program Project supported by program project grants from the National Institute of General Medical Sciences and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the medical records of the Olmsted Medical Group and Community Hospital were indexed for retrieval by the same system as the Mayo Clinic. Those of other outside sources such as the University of Minnesota Hospital, Rochester State Hospital, and Veterans Hospitals which pertained to the occasional admission of Olmsted County residents were also added to the Mayo Clinic maintained diagnostic index. The resulting central diagnostic file gave virtually complete case assignments for diagnosed cases of myocardial infarction, sudden unexpected death, angina pectoris, and noncoronary heart disease.
DESIGN NARRATIVE:
The centralized case index of the Mayo Clinic and the Rochester Epidemiology Program Project were used to identify any Rochester resident with a diagnosis between 1950 and 1987 of any condition suggesting that coronary heart disease might be present. Included were diagnoses of coronary heart disease, myocardial infarction, angina pectoris, coronary insufficiency, or arrhythmias. All relevant index codes were specified and a computer generated list was provided of the unit record numbers of all candidate cases. The medical histories were then retrieved and reviewed for inclusion. The screened histories were assigned to nurse abstractors whose duty it was to identify from the screening list those patients who satisfied the diagnostic criteria in the protocol as well as the incidence and residence requirements. In case finding of coronary heart disease incidence, the following had to be true: the diagnosis of angina pectoris, myocardial infarction or sudden unexpected death must have satisfied the protocol's diagnostic criteria; the diagnosis must have been a first diagnosis; the patient, at the time of first diagnosis, must have been free of diagnoses of congestive heart failure and valvular heart disease; the patient must have been a resident of Rochester at the time of diagnosis. If all of these criteria were met, the electrocardiograms were read by a physician for case verification. A precoded abstract of the history was prepared for each incidence case. The abstract included: identification and demographic data; information on smoking, hypertension, hypertension therapy, lipids, and use of estrogens; diagnostic factors such as ECG, treatment tests, angiography, and selected laboratory test results. The first myocardial infarction following the first coronary heart disease diagnosis was coded; if the first manifestation of coronary heart disease was a myocardial infarction, the second myocardial infarction was coded to provide a basis for determining reinfarction rates. In the earlier study done from 1950-1969, little data on treatment were abstracted. From 1970 to 1991t, drugs and surgery were abstracted. All death certificates for Rochester and Olmsted County residents for the period 1960-1979 were recoded to the 8th revision of the ICDA in order to obtain comparability over the study period. All deaths suspected of being due to some form of coronary heart disease were reviewed by a group of cardiologists using a clinical classification of death. The cardiologists used medical, hospital, and autopsy records to determine cause of death. Follow up was 99 percent complete. Date of last follow-up and cause of death were recorded.
The medical records for all Olmsted County residents ages 30 and over coming to autopsy for the period 1950-1978 were reviewed. Data abstracted included date of death, age at death, sex, weight, heart weight, grade of lesions in the coronary arteries, and evidence of recent or old myocardial infarction. All autopsy records for 1980 through 1984 were reviewed for coronary heart disease. Beginning in 1986, valvular heart disease data were also collected for the period 1950 through 1987.
The effect of the Diagnostic Related Groups (DRG) on incidence rates for coronary and valvular heart disease was ascertained for all cases hospitalized after January 1, 1984. The Mayo Medical Center DRG system which captured and retained diagnoses on hospitalized patients was compared with the study medical index files.
Incident cases were also followed for specific diagnostic and therapeutic procedures. This was accomplished by record review and by matching lists of case patient numbers with identification numbers of patients who underwent the following: radionuclide ejection fractions and radionuclide exercise tests beginning in 1980; arteriography, ventriculography, valve evaluation, thrombolytic infusion, percutaneous transluminal coronary angioplasty or balloon angioplasty, and electrophysiologic testing beginning in 1976; coronary artery bypass surgery, myocardial resection, and valve repair or replacement beginning in 1978; coronary intensive care unit data beginning in 1976. New procedures were monitored as they came into use.
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 7300444Connolly DC, Oxman HA, Nobrega FT, Kurland LT, Kennedy MA, Elveback LR. Coronary heart disease in residents of Rochester, Minnesota, 1950-1975. I. Background and study design. Mayo Clin Proc. 1981 Nov;56(11):661-4.
- Background: PubMed 7300445Elveback LR, Connolly DC, Kurland LT. Coronary heart disease in residents of Rochester, Minnesota. II. Mortality, incidence, and survivorship, 1950-1975. Mayo Clin Proc. 1981 Nov;56(11):665-72.
- Background: PubMed 7132431Beard CM, Fuster V, Elveback LR. Daily and seasonal variation in sudden cardiac death, Rochester, Minnesota, 1950-1975. Mayo Clin Proc. 1982 Nov;57(11):704-6.
- Background: PubMed 6834892Connolly DC, Elveback LR, Oxman HA. Coronary heart disease in residents of Rochester, Minnesota, 1950-1975. III. Effect of hypertension and its treatment on survival of patients with coronary artery disease. Mayo Clin Proc. 1983 Apr;58(4):249-54.
- Background: PubMed 6708602Connolly DC, Elveback LR, Oxman HA. Coronary heart disease in residents of Rochester, Minnesota. IV. Prognostic value of the resting electrocardiogram at the time of initial diagnosis of angina pectoris. Mayo Clin Proc. 1984 Apr;59(4):247-50. doi: 10.1016/s0025-6196(12)61257-9.
- Background: PubMed 6139670Garraway WM, Elveback LR, Connolly DC, Whisnant JP. The dichotomy of myocardial and cerebral infarction. Lancet. 1983 Dec 10;2(8363):1332-5. doi: 10.1016/s0140-6736(83)91091-7.
- Background: PubMed 6741912Beard CM, Fuster V, Annegers JF. Reproductive history in women with coronary heart disease. A case-control study. Am J Epidemiol. 1984 Jul;120(1):108-14. doi: 10.1093/oxfordjournals.aje.a113859.
- Background: PubMed 3990378Elveback LR, Connolly DC. Coronary heart disease in residents of Rochester, Minnesota. V. Prognosis of patients with coronary heart disease based on initial manifestation. Mayo Clin Proc. 1985 May;60(5):305-11. doi: 10.1016/s0025-6196(12)60537-0.
- Background: PubMed 3999808Connolly DC, Elveback LR. Coronary heart disease in residents of Rochester, Minnesota. VI. Hospital and posthospital course of patients with transmural and subendocardial myocardial infarction. Mayo Clin Proc. 1985 Jun;60(6):375-81. doi: 10.1016/s0025-6196(12)60846-5.
- Background: PubMed 3762228Elveback LR, Connolly DC, Melton LJ 3rd. Coronary heart disease in residents of Rochester, Minnesota. VII. Incidence, 1950 through 1982. Mayo Clin Proc. 1986 Nov;61(11):896-900. doi: 10.1016/s0025-6196(12)62612-3.
- Background: PubMed 2765259Kottke TE, Gatewood LC, Park HA. Using serum cholesterol to identify high risk and stimulate behavior change: will it work? Ann Med. 1989 Jun;21(3):181-7. doi: 10.3109/07853898909149930.
- Background: PubMed 2557493Beard CM, Kottke TE, Annegers JF, Ballard DJ. The Rochester Coronary Heart Disease Project: effect of cigarette smoking, hypertension, diabetes, and steroidal estrogen use on coronary heart disease among 40- to 59-year-old women, 1960 through 1982. Mayo Clin Proc. 1989 Dec;64(12):1471-80. doi: 10.1016/s0025-6196(12)65702-4.
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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?
On the ClinicalTrials.gov record for NCT00005148, which also lists 32 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.