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Coronary-Prone Behavior and Cardiovascular Reactivity

26 de febrero de 2016 actualizado por: National Heart, Lung, and Blood Institute (NHLBI)
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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

No mayor que 100 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Descripción

No eligibility criteria

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 1978

Finalización del estudio (Actual)

1 de junio de 1991

Fechas de registro del estudio

Enviado por primera vez

25 de mayo de 2000

Primero enviado que cumplió con los criterios de control de calidad

25 de mayo de 2000

Publicado por primera vez (Estimar)

26 de mayo de 2000

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

29 de febrero de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

26 de febrero de 2016

Última verificación

1 de abril de 2000

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 1015
  • R01HL036027 (Subvención/contrato del NIH de EE. UU.)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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