Cardiovascular DiseasesNCT00005144
Coronary-Prone Behavior and Cardiovascular Reactivity
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To further clarify the concept of coronary-prone behavior and to develop methods of assessing coronary-prone behavior. Specifically, to revise the component scoring system for Potential for Hostility in the Structured Interviews measure of Type A behavior. 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
- Aug 1978to Jun 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 further clarify the concept of coronary-prone behavior and to develop methods of assessing coronary-prone behavior. Specifically, to revise the component scoring system for Potential for Hostility in the Structured Interviews measure of Type A behavior.
Read the detailed description
BACKGROUND:
In 1978, a select Review Panel of biomedical and behavioral scientists met under the auspices of the NIH to evaluate the data linking the Type A behavior pattern to coronary heart disease. Based on the scientific evidence available to them in December, 1978, the members of the Panel issued a report in which they concluded that the Type A behavior pattern was an independent risk factor for coronary heart disease, of a magnitude similar to that of other established risk factors, such as cigarette smoking and serum cholesterol.
At the time the Panel met, the most impressive evidence linking the Type A behavior pattern to coronary heart disease was the prospective Western Collaborative Group Study (WCGS), which established a significant risk ratio for Structured Interview-assessed Type A behavior pattern for all clinical manifestations of coronary heart disease; and three angiographic studies which reported significant associations between Structured Interview-defined Type A behavior pattern and severity of coronary artery disease. Supporting evidence was provided by prevalence studies employing the Jenkins Activity Survey (JAS) measure of Type A behavior pattern, and by incidence and prevalence data from the Framingham study, using a six-item scale thought to assess aspects of Type A behavior.
Subsequent to the conference, studies had begun to emerge which called into question the robustness of the association between the Type A behavior pattern and various manifestations of coronary heart disease. The most damaging of these was the prospective Type A study included in MRFIT. In this study, 3,110 men were given the Structured Interview and Jenkins Activity Survey, and followed for an average period of seven years, while receiving annual medical examinations. Analysis of the results at the end of the seven years revealed that Type A behavior pattern, however assessed, was completely unrelated to either coronary death or documented myocardial infarction.
A major tool was the component scoring system for the Structured Interview to determine which of the many attributes comprising the multidimensional Type A behavior pattern were actually associated with coronary heart disease. Component scoring had demonstrated that some components had consistent associations with coronary heart disease, even when the global Type A behavior pattern showed no relationship. Component analysis of the Type A behavior pattern in MRFIT revealed that of all the attributes assessed, only Potential for Hostility was significantly related to incidence of coronary heart disease. Several other studies were conducted under this project. Tape-recorded Structured Interviews from the Western Collaborative Group Study were reanalyzed to assess the relationship between components of Type A behavior and incidence of coronary heart disease. Rescoring was completed on Structured Interviews of over 1,000 subjects who had undergone stress testing while blood pressure and heart rate were recorded. An analysis was also conducted on the influence of cigarette smoking and situational stress on cardiovascular response in young male subjects.
DESIGN NARRATIVE:
In Study I, tape-recorded Structured Interviews from MRFIT were re-scored for Potential for Hostility. In Study II, Structured Interviews were obtained from a new sample of participants in the BLSA. In the BLSA the Structured Interview were expanded to include questions that dealt more directly and sampled more fully antagonistic self-descriptions, attitudes, and behaviors. Alternative measures of Agreeableness-Antagonism were already available from the BLSA sample that were used to validate scores from the expanded Structured Interview, and biomedical information on BLSA participants was used to further test the predictive utility of Antagonistic Hostility as a risk factor for coronary heart disease. Previous research had scored Potential for Hostility from the Structured Interview by examining Content, Intensity, and Style as well as a clinical judgement of Total Potential for Hostility. In the present study, Antagonistic Hostility was measured in terms of Antagonistic Style and Self-Descriptions. A total score was defined as the sum of these two components. Antagonistic Style was scored using a 5-point scale when rudeness, condescension, and disagreeableness were expressed toward the interviewer. Matched and unmatched logistic regressions were used to evaluate Antagonistic Hostility as a risk factor for morbidity and mortality outcomes. Multivariate analyses were used to control for other standard risk factors.
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
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
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 1978
- Study completionJun 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (62)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
- NCT00005144
- Sponsor's protocol ID
- 1015
- Other IDs
- R01HL036027
- Status last verified
- Apr 2000
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Dembroski TM, MacDougall JM: Stress and Cigarette Smoking: Implications for Cardiovascular Risk. In: Schmidt TH, Dembroski TM, Blumchen G (Eds), Biological and Psychological Factors in Cardiovascular Disease. New York, Springer Verlag. pp 246-257, 1986
Dembroski TM: Overview of Classic and Stress-Related Risk Factors: Relationship to Substance Effects on Reactivity. Matthews KA et al (Eds), Handbook of Stress, Reactivity, and Cardiovascular Disease. New York, Wiley, pp 275-289, 1986
Dembroski TM, MacDougall JM, Williams RB: Reply to Professor Steptoe. Psychosom Med, 5:371-373, 1986
MacDougall JM, Musante L, Howard JA, Hanes RL, Dembroski TM. Individual differences in cardiovascular reactions to stress and cigarette smoking. Health Psychol. 1986;5(6):531-544. doi: 10.1037/0278-6133.5.6.531.
PubMed 3803349Matthews KA, Weiss S, Detre T, Dembroski TM, Faulkner B, Manuck S, Williams RB (Eds): Handbook of Stress, Reactivity, and Cardiovascular Disease. New York, Wiley, 1986
Schmidt TH, Dembroski TM, Blumchen G (Eds): Biological and Psychological Factors in Cardiovascular Disease. New York, Springer Verlag, 1986
Siegman AW, Dembroski TM, Ringel N. Components of hostility and the severity of coronary artery disease. Psychosom Med. 1987 Mar-Apr;49(2):127-35. doi: 10.1097/00006842-198703000-00003.
PubMed 3575601Dembroski TM, Costa PT Jr. Coronary prone behavior: components of the type A pattern and hostility. J Pers. 1987 Jun;55(2):211-35. doi: 10.1111/j.1467-6494.1987.tb00435.x.
PubMed 3612469Krantz DS, Contrada RJ, LaRiccia PJ, Anderson JR, Durel LA, Dembroski TM, Weiss T. Effects of beta-adrenergic stimulation and blockade on cardiovascular reactivity, affect, and type A behavior. Psychosom Med. 1987 Mar-Apr;49(2):146-58. doi: 10.1097/00006842-198703000-00005.
PubMed 3575603Dembroski TM. Exercise hypertension: behavior and the dynamic action of risk factors. Herz. 1987 Apr;12(2):134-40.
PubMed 3583206Costa PT, et al: Hostility, Agreeableness-Antagonism and Coronary Heart Disease. J Holistic Med, 1987
Herd JA, Falkner B, Anderson DE, Costa PD Jr, Dembroski TM, Hendrix GH, Henry JP, Kaplan JR, Light KC, Schneiderman N, et al. Psychophysiologic factors in hypertension. Circulation. 1987 Jul;76(1 Pt 2):I89-94. No abstract available.
PubMed 3297414Dembroski TM, MacDougall JM, Lushene R. Interpersonal interaction and cardiovascular response in type A subjects and coronary patients. J Human Stress. 1979 Dec;5(4):28-36. doi: 10.1080/0097840x.1979.10545992.
PubMed 521622MacDougall JM, Dembroski TM, Musante L. The structured interview and questionnaire methods of assessing coronary-prone behavior in male and female college students. J Behav Med. 1979 Mar;2(1):71-83. doi: 10.1007/BF00846564.
PubMed 555481Dembroski TM, MacDougall JM, Herd JA, Shields JL: Effects of Level of Challenge on Pressor and Heart Rate Responses in Type A and B Subjects. J Appl Social Psychol, 9:209-228, 1979
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
- Coronary-Prone Behavior and Cardiovascular Reactivity
- ClinicalTrials.gov ID
- NCT00005144
- Acronym / sponsor ID
- 1015
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1978
- Study completion
- Jun 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 further clarify the concept of coronary-prone behavior and to develop methods of assessing coronary-prone behavior. Specifically, to revise the component scoring system for Potential for Hostility in the Structured Interviews measure of Type A behavior.
Detailed description
BACKGROUND:
In 1978, a select Review Panel of biomedical and behavioral scientists met under the auspices of the NIH to evaluate the data linking the Type A behavior pattern to coronary heart disease. Based on the scientific evidence available to them in December, 1978, the members of the Panel issued a report in which they concluded that the Type A behavior pattern was an independent risk factor for coronary heart disease, of a magnitude similar to that of other established risk factors, such as cigarette smoking and serum cholesterol.
At the time the Panel met, the most impressive evidence linking the Type A behavior pattern to coronary heart disease was the prospective Western Collaborative Group Study (WCGS), which established a significant risk ratio for Structured Interview-assessed Type A behavior pattern for all clinical manifestations of coronary heart disease; and three angiographic studies which reported significant associations between Structured Interview-defined Type A behavior pattern and severity of coronary artery disease. Supporting evidence was provided by prevalence studies employing the Jenkins Activity Survey (JAS) measure of Type A behavior pattern, and by incidence and prevalence data from the Framingham study, using a six-item scale thought to assess aspects of Type A behavior.
Subsequent to the conference, studies had begun to emerge which called into question the robustness of the association between the Type A behavior pattern and various manifestations of coronary heart disease. The most damaging of these was the prospective Type A study included in MRFIT. In this study, 3,110 men were given the Structured Interview and Jenkins Activity Survey, and followed for an average period of seven years, while receiving annual medical examinations. Analysis of the results at the end of the seven years revealed that Type A behavior pattern, however assessed, was completely unrelated to either coronary death or documented myocardial infarction.
A major tool was the component scoring system for the Structured Interview to determine which of the many attributes comprising the multidimensional Type A behavior pattern were actually associated with coronary heart disease. Component scoring had demonstrated that some components had consistent associations with coronary heart disease, even when the global Type A behavior pattern showed no relationship. Component analysis of the Type A behavior pattern in MRFIT revealed that of all the attributes assessed, only Potential for Hostility was significantly related to incidence of coronary heart disease. Several other studies were conducted under this project. Tape-recorded Structured Interviews from the Western Collaborative Group Study were reanalyzed to assess the relationship between components of Type A behavior and incidence of coronary heart disease. Rescoring was completed on Structured Interviews of over 1,000 subjects who had undergone stress testing while blood pressure and heart rate were recorded. An analysis was also conducted on the influence of cigarette smoking and situational stress on cardiovascular response in young male subjects.
DESIGN NARRATIVE:
In Study I, tape-recorded Structured Interviews from MRFIT were re-scored for Potential for Hostility. In Study II, Structured Interviews were obtained from a new sample of participants in the BLSA. In the BLSA the Structured Interview were expanded to include questions that dealt more directly and sampled more fully antagonistic self-descriptions, attitudes, and behaviors. Alternative measures of Agreeableness-Antagonism were already available from the BLSA sample that were used to validate scores from the expanded Structured Interview, and biomedical information on BLSA participants was used to further test the predictive utility of Antagonistic Hostility as a risk factor for coronary heart disease. Previous research had scored Potential for Hostility from the Structured Interview by examining Content, Intensity, and Style as well as a clinical judgement of Total Potential for Hostility. In the present study, Antagonistic Hostility was measured in terms of Antagonistic Style and Self-Descriptions. A total score was defined as the sum of these two components. Antagonistic Style was scored using a 5-point scale when rudeness, condescension, and disagreeableness were expressed toward the interviewer. Matched and unmatched logistic regressions were used to evaluate Antagonistic Hostility as a risk factor for morbidity and mortality outcomes. Multivariate analyses were used to control for other standard risk factors.
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.
- BackgroundDembroski TM, MacDougall JM: Stress and Cigarette Smoking: Implications for Cardiovascular Risk. In: Schmidt TH, Dembroski TM, Blumchen G (Eds), Biological and Psychological Factors in Cardiovascular Disease. New York, Springer Verlag. pp 246-257, 1986
- BackgroundDembroski TM: Overview of Classic and Stress-Related Risk Factors: Relationship to Substance Effects on Reactivity. Matthews KA et al (Eds), Handbook of Stress, Reactivity, and Cardiovascular Disease. New York, Wiley, pp 275-289, 1986
- BackgroundDembroski TM, MacDougall JM, Williams RB: Reply to Professor Steptoe. Psychosom Med, 5:371-373, 1986
- Background: PubMed 3803349MacDougall JM, Musante L, Howard JA, Hanes RL, Dembroski TM. Individual differences in cardiovascular reactions to stress and cigarette smoking. Health Psychol. 1986;5(6):531-544. doi: 10.1037/0278-6133.5.6.531.
- BackgroundMatthews KA, Weiss S, Detre T, Dembroski TM, Faulkner B, Manuck S, Williams RB (Eds): Handbook of Stress, Reactivity, and Cardiovascular Disease. New York, Wiley, 1986
- BackgroundSchmidt TH, Dembroski TM, Blumchen G (Eds): Biological and Psychological Factors in Cardiovascular Disease. New York, Springer Verlag, 1986
- Background: PubMed 3575601Siegman AW, Dembroski TM, Ringel N. Components of hostility and the severity of coronary artery disease. Psychosom Med. 1987 Mar-Apr;49(2):127-35. doi: 10.1097/00006842-198703000-00003.
- Background: PubMed 3612469Dembroski TM, Costa PT Jr. Coronary prone behavior: components of the type A pattern and hostility. J Pers. 1987 Jun;55(2):211-35. doi: 10.1111/j.1467-6494.1987.tb00435.x.
- Background: PubMed 3575603Krantz DS, Contrada RJ, LaRiccia PJ, Anderson JR, Durel LA, Dembroski TM, Weiss T. Effects of beta-adrenergic stimulation and blockade on cardiovascular reactivity, affect, and type A behavior. Psychosom Med. 1987 Mar-Apr;49(2):146-58. doi: 10.1097/00006842-198703000-00005.
- Background: PubMed 3583206Dembroski TM. Exercise hypertension: behavior and the dynamic action of risk factors. Herz. 1987 Apr;12(2):134-40.
- BackgroundCosta PT, et al: Hostility, Agreeableness-Antagonism and Coronary Heart Disease. J Holistic Med, 1987
- Background: PubMed 3297414Herd JA, Falkner B, Anderson DE, Costa PD Jr, Dembroski TM, Hendrix GH, Henry JP, Kaplan JR, Light KC, Schneiderman N, et al. Psychophysiologic factors in hypertension. Circulation. 1987 Jul;76(1 Pt 2):I89-94. 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.
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 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 NCT00005144, which also lists 62 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 29 Feb 2016.