Cardiovascular DiseasesNCT00005192
Psychophysiology of Cardiovascular Reactivity
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Miami.
Trial summary
To determine why Black Americans have a higher prevalence of hypertension than whites by examining the interactions of psychosocial stressors and suppressed hostility with genetic or constitutional factors. Read more about this study
- Who is it for?
- Ages 25 to 54 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1986to Jun 2006
- 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 25 to 54 years
- Men only
- No healthy volunteers
- Adult
No eligibility criteria
About this study
To determine why Black Americans have a higher prevalence of hypertension than whites by examining the interactions of psychosocial stressors and suppressed hostility with genetic or constitutional factors.
Read the detailed description
BACKGROUND:
Blacks in the United States have a much greater prevalence of essential hypertension than whites. The prevalence of hypertension for adults aged 18-74 has been estimated at 15.7 percent for white women, 18.5 percent for white men, 27.8 percent for Black men and 28.6 percent for Black women. Among adults who underwent screening for the Hypertension Detection and Follow-up Program, 36.2 percent of Black males and 38.2 percent of Black females either had diastolic blood pressures at least as high as 95 mmHg or were taking antihypertensive medications. The Black-white ratio for the prevalence of hypertension in this survey was approximately 2. Reportedly, the prevalence of hypertension among inner city Blacks may be as high as 50 percent. The exact causes of the disparity in hypertension prevalence between Blacks and whites are unknown, but genetic predisposition, psychosocial stress, and life-style factors such as high sodium ingestion and obesity have been implicated. None of these factors alone appears sufficient to account for the difference in the prevalence of hypertension between Blacks and whites, suggesting that multiple factors and/or interactions between factors may be involved.
DESIGN NARRATIVE:
The study is supported by a program project grant and thus includes many subprojects. Projects 1A through 1C were supported beginning in 1986. Project 1A examined the effects of cardiovascular and hormonal responses to standardized laboratory challenges as a function of race, sex, age, and normal blood pressure versus borderline hypertension. The subjects were classified according to four categories: Black or white race; male or female sex; normal or raised blood pressure; and ages 25-39 or 40-54, giving a total of 16 cells with 15 subjects in each. The subjects were given a physical examination, electrocardiogram, blood screening test as well as a battery of special tests including a Structured Interview for Type A behavior pattern, playing a video game, a test designed to elicit anger, and exercise on a bicycle ergometer. During these tasks subjects were monitored for heart rate and blood pressure, and blood was sampled for plasma catecholamines, renin, cortisol, aldosterone, and vasopressin. Various psychological tests were administered including the Cook-Medley hostility scale, the Life Orientation test, a job stress scale, the John Henryism Active Coping Scale and others. Urine samples were collected for electrolyte and catecholamine excretion and ambulatory blood pressure was monitored on a work day and on a non-work day.
Project IB examined the effects of acute sodium loading and depletion on cardiovascular and hormonal reactivity as a function of race and sex. Normotensive subjects were classified according to two categories: Black or white race; male or female sex, with four cells of 15 subjects each. After the initial medical examination, subjects were seen three times at intervals of two weeks. Before each visit three overnight urine collections were made for electrolyte excretion evaluation. On these three visits subjects were randomized to either a control day, a sodium loading day, or sodium depletion day. On each of these days subjects were given three reactivity tests including the video game, exercise test, and speech-stressor task. The same psychological tests as in Project 1A were given on the mornings of the three testing days.
Project 1C was a five-year follow-up of 80 subjects in the Study of Biobehavioral Factors Affecting Hypertension in Blacks. Subjects had a routine history and physical exam and were then given the Type A Interview, a video game, and an exercise task. Subjects also provided three overnight urine samples.
Two substudies were also conducted. The goal of substudy 1 was to determine what psychosocial factors predicted cardiovascular responding at work in Black and white women. Black and white normotensive nurses between the ages of 20-45 years served as subjects. Substudy 2 examined the affective and physiological responses of Black and white college students during challenge. Normotensive Black and white men and women were monitored for blood pressure and heart rate during rest and during three tasks including mirror star tracing, hand immersion cold pressor, and speech stressor.
The program project was renewed in 1996. Subproject 7 addresses the the problem of modifying risk in youth with high blood pressure. The subproject compares adolescents with high versus normal blood pressure in terms of fasting insulin, oral glucose tolerance, adiposity, aerobic fitness, diet, cardiac mass, autonomic reactivity, psychosocial characteristics and family medical history. Subproject 7 renewed as Subproject 1 in FY 2001 examines the long-term effects of three intervention conditions: a three month self-management intervention; a six month augmented self-management skill acquisition intervention program; and usual care. Subproject 8 renewed as Subproject 2 in FY 2001 involves behavioral intervention in post-myocardial infarction patients receiving standard pharmacological treatment or standard pharmacological treatment plus behavioral treatment including stress management, dietary supervision, and self-directed exercise.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, 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 startJul 1986
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)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 University of MiamiThe 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
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Neil Schneiderman, University of Miami
- Investigators
- Neil Schneiderman, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005192
- Sponsor's protocol ID
- 1071
- Other IDs
- P01HL036588
- Status last verified
- Jan 2016
- First submitted
- 25 May 2000
- Last updated
- 15 Jan 2016
- Results posted
- No
Publications
Gellman MD, Ironson GH, Spitzer SB, Keenan M, Schneiderman N, Weidler DJ: Ambulatory Blood Pressure as a Function of Race, Gender, Place, and Mood. Circulation, 74(Suppl.)2, 319, 1986
Spitzer SB, Carver CS, Gerace TA, Tischenkel N, Gellman M, Schneiderman N: Locus of Control, John Henryism, Monitoring-Blunting, and Reactivity in the Miami Minority Hypertension Project. Society of Behavioral Medicine, 1986
Tischenkel N, Schneiderman N, Nelesen R, Vorp R, Gellman M, Gerace T, McCabe PM: Cardiovascular and Neurohumoral Baselines and Reactivity in the Miami Minority Hypertension Project. Society of Behavioral Medicine, 1986
Weintraub JK, Carver CS, McCabe PM, Spitzer S, Schneiderman J: Anger, Hostility, and Reactivity in the Miami Minority Hypertension Project. Society of Behavioral Medicine, 1986
Tishenkel N, Gellman M, Nelesen R, Schneiderman N: Behavioral Factors Affecting Blood Pressure in Blacks. Cardiovascular Disease Epidemiology Newsletter, 315, 1986
Larsen P, Schneiderman N, Pasin RD: Physiological Bases of Cardiovascular Psychophysiology. In: Coles M, Donchin E, Porges S (Eds), Psychophysiology: Systems, Processes and Applications. Guilford, 1986
Kaufman MP, Schneiderman N: Physiological Bases of Respiratory Psychophysiology. In: Coles M, Donchin E, Porges S (Eds), Psychophysiology: Systems, Processes and Applications. Guilford, 1986
Dimsdale J, Alpert B, Schneiderman N: Exercise as a Modulator of Cardiovascular Reactivity. In: Matthews K et al (Ed), Handbook of Stress, Reactivity, and Cardiovascular Disease. Wiley, 1986
Schneiderman N, Pickering T: Cardiovascular Measures of Physiologic Reactivity. In: Matthews K et al (Ed), Handbook of Stress, Reactivity, and Cardiovascular Disease. Wiley, 1986
Schneiderman N, Tischenkel N, Nelesen R: Anger, Aerobics, and Autonomic Reactivity. In: Schmidt T, Dembroski T, Blumchen C (Eds), Biological and Psychological Factors in Cardiovascular Disease. Springer, 1986
Schneiderman N. Psychophysiologic factors in atherogenesis and coronary artery disease. Circulation. 1987 Jul;76(1 Pt 2):I41-7.
PubMed 3297408Ironson G, Gellman M, Spitzer S, Llabre M, Schneiderman N: Prediction of Ambulatory Blood Pressure as a Function of Laboratory Reactivity, Race, and Gender. Society of Behavioral Medicine, 1987
Laperriere AR, VanDercar DH, Shyu LY, Ward MF, McCabe PM, Perry AC, Mosher PE, Schneiderman N. Microcomputer servo-controlled bicycle ergometer system for psychophysiological research. Psychophysiology. 1989 Mar;26(2):201-7. doi: 10.1111/j.1469-8986.1989.tb03157.x.
PubMed 2727222Llabre MM, Ironson GH, Spitzer SB, Gellman MD, Weidler DJ, Schneiderman N. How many blood pressure measurements are enough? An application of generalizability theory to the study of blood pressure reliability. Psychophysiology. 1988 Jan;25(1):97-106. doi: 10.1111/j.1469-8986.1988.tb00967.x. No abstract available.
PubMed 3353490Schneiderman N, McCabe, PM: Psychophysiologic Strategies in Laboratory Research. In: Schneiderman N, Kaufmann P, Weiss SM (Eds), Handbook of Research Methods in Cardiovascular Behavioral Medicine. Plenum Press, New York, 1988
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiology of Cardiovascular Reactivity
- ClinicalTrials.gov ID
- NCT00005192
- Acronym / sponsor ID
- 1071
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1986
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (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 why Black Americans have a higher prevalence of hypertension than whites by examining the interactions of psychosocial stressors and suppressed hostility with genetic or constitutional factors.
Detailed description
BACKGROUND:
Blacks in the United States have a much greater prevalence of essential hypertension than whites. The prevalence of hypertension for adults aged 18-74 has been estimated at 15.7 percent for white women, 18.5 percent for white men, 27.8 percent for Black men and 28.6 percent for Black women. Among adults who underwent screening for the Hypertension Detection and Follow-up Program, 36.2 percent of Black males and 38.2 percent of Black females either had diastolic blood pressures at least as high as 95 mmHg or were taking antihypertensive medications. The Black-white ratio for the prevalence of hypertension in this survey was approximately 2. Reportedly, the prevalence of hypertension among inner city Blacks may be as high as 50 percent. The exact causes of the disparity in hypertension prevalence between Blacks and whites are unknown, but genetic predisposition, psychosocial stress, and life-style factors such as high sodium ingestion and obesity have been implicated. None of these factors alone appears sufficient to account for the difference in the prevalence of hypertension between Blacks and whites, suggesting that multiple factors and/or interactions between factors may be involved.
DESIGN NARRATIVE:
The study is supported by a program project grant and thus includes many subprojects. Projects 1A through 1C were supported beginning in 1986. Project 1A examined the effects of cardiovascular and hormonal responses to standardized laboratory challenges as a function of race, sex, age, and normal blood pressure versus borderline hypertension. The subjects were classified according to four categories: Black or white race; male or female sex; normal or raised blood pressure; and ages 25-39 or 40-54, giving a total of 16 cells with 15 subjects in each. The subjects were given a physical examination, electrocardiogram, blood screening test as well as a battery of special tests including a Structured Interview for Type A behavior pattern, playing a video game, a test designed to elicit anger, and exercise on a bicycle ergometer. During these tasks subjects were monitored for heart rate and blood pressure, and blood was sampled for plasma catecholamines, renin, cortisol, aldosterone, and vasopressin. Various psychological tests were administered including the Cook-Medley hostility scale, the Life Orientation test, a job stress scale, the John Henryism Active Coping Scale and others. Urine samples were collected for electrolyte and catecholamine excretion and ambulatory blood pressure was monitored on a work day and on a non-work day.
Project IB examined the effects of acute sodium loading and depletion on cardiovascular and hormonal reactivity as a function of race and sex. Normotensive subjects were classified according to two categories: Black or white race; male or female sex, with four cells of 15 subjects each. After the initial medical examination, subjects were seen three times at intervals of two weeks. Before each visit three overnight urine collections were made for electrolyte excretion evaluation. On these three visits subjects were randomized to either a control day, a sodium loading day, or sodium depletion day. On each of these days subjects were given three reactivity tests including the video game, exercise test, and speech-stressor task. The same psychological tests as in Project 1A were given on the mornings of the three testing days.
Project 1C was a five-year follow-up of 80 subjects in the Study of Biobehavioral Factors Affecting Hypertension in Blacks. Subjects had a routine history and physical exam and were then given the Type A Interview, a video game, and an exercise task. Subjects also provided three overnight urine samples.
Two substudies were also conducted. The goal of substudy 1 was to determine what psychosocial factors predicted cardiovascular responding at work in Black and white women. Black and white normotensive nurses between the ages of 20-45 years served as subjects. Substudy 2 examined the affective and physiological responses of Black and white college students during challenge. Normotensive Black and white men and women were monitored for blood pressure and heart rate during rest and during three tasks including mirror star tracing, hand immersion cold pressor, and speech stressor.
The program project was renewed in 1996. Subproject 7 addresses the the problem of modifying risk in youth with high blood pressure. The subproject compares adolescents with high versus normal blood pressure in terms of fasting insulin, oral glucose tolerance, adiposity, aerobic fitness, diet, cardiac mass, autonomic reactivity, psychosocial characteristics and family medical history. Subproject 7 renewed as Subproject 1 in FY 2001 examines the long-term effects of three intervention conditions: a three month self-management intervention; a six month augmented self-management skill acquisition intervention program; and usual care. Subproject 8 renewed as Subproject 2 in FY 2001 involves behavioral intervention in post-myocardial infarction patients receiving standard pharmacological treatment or standard pharmacological treatment plus behavioral treatment including stress management, dietary supervision, and self-directed exercise.
Study design
Who may qualify
- Ages
- 25 to 54 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 15 Jan 2016.
- BackgroundGellman MD, Ironson GH, Spitzer SB, Keenan M, Schneiderman N, Weidler DJ: Ambulatory Blood Pressure as a Function of Race, Gender, Place, and Mood. Circulation, 74(Suppl.)2, 319, 1986
- BackgroundSpitzer SB, Carver CS, Gerace TA, Tischenkel N, Gellman M, Schneiderman N: Locus of Control, John Henryism, Monitoring-Blunting, and Reactivity in the Miami Minority Hypertension Project. Society of Behavioral Medicine, 1986
- BackgroundTischenkel N, Schneiderman N, Nelesen R, Vorp R, Gellman M, Gerace T, McCabe PM: Cardiovascular and Neurohumoral Baselines and Reactivity in the Miami Minority Hypertension Project. Society of Behavioral Medicine, 1986
- BackgroundWeintraub JK, Carver CS, McCabe PM, Spitzer S, Schneiderman J: Anger, Hostility, and Reactivity in the Miami Minority Hypertension Project. Society of Behavioral Medicine, 1986
- BackgroundTishenkel N, Gellman M, Nelesen R, Schneiderman N: Behavioral Factors Affecting Blood Pressure in Blacks. Cardiovascular Disease Epidemiology Newsletter, 315, 1986
- BackgroundLarsen P, Schneiderman N, Pasin RD: Physiological Bases of Cardiovascular Psychophysiology. In: Coles M, Donchin E, Porges S (Eds), Psychophysiology: Systems, Processes and Applications. Guilford, 1986
- BackgroundKaufman MP, Schneiderman N: Physiological Bases of Respiratory Psychophysiology. In: Coles M, Donchin E, Porges S (Eds), Psychophysiology: Systems, Processes and Applications. Guilford, 1986
- BackgroundDimsdale J, Alpert B, Schneiderman N: Exercise as a Modulator of Cardiovascular Reactivity. In: Matthews K et al (Ed), Handbook of Stress, Reactivity, and Cardiovascular Disease. Wiley, 1986
- BackgroundSchneiderman N, Pickering T: Cardiovascular Measures of Physiologic Reactivity. In: Matthews K et al (Ed), Handbook of Stress, Reactivity, and Cardiovascular Disease. Wiley, 1986
- BackgroundSchneiderman N, Tischenkel N, Nelesen R: Anger, Aerobics, and Autonomic Reactivity. In: Schmidt T, Dembroski T, Blumchen C (Eds), Biological and Psychological Factors in Cardiovascular Disease. Springer, 1986
- Background: PubMed 3297408Schneiderman N. Psychophysiologic factors in atherogenesis and coronary artery disease. Circulation. 1987 Jul;76(1 Pt 2):I41-7.
- BackgroundIronson G, Gellman M, Spitzer S, Llabre M, Schneiderman N: Prediction of Ambulatory Blood Pressure as a Function of Laboratory Reactivity, Race, and Gender. Society of Behavioral Medicine, 1987
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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.
Neil Schneiderman
University of Miami
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Miami.
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 15 Jan 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 NCT00005192, which also lists 44 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 15 Jan 2016.