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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005337
Other study ID # 4196
Secondary ID R01HL044998
Status Completed
Phase N/A
First received May 25, 2000
Last updated February 17, 2016
Start date April 1991
Est. completion date March 1995

Study information

Verified date March 2005
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To determine whether deficient vagal antagonism of sympathetic nervous system (SNS) actions on the heart contributed to increased coronary heart disease risk in hostile persons.


Description:

DESIGN NARRATIVE:

Sophisticated electrophysiologic monitoring approaches were used to: 1) show greater sensitivity in nonhostile young men to T-wave attenuation effects of isoproterenol infusion following vagal blockade; 2) show that vagal enhancement reduced and shortened the T-wave attenuation effects of isoproterenol infusion more in hostile young men; 3) evaluate these effects of vagal blockage and enhancement in middle-aged men and in young and middle-aged women; and 4) relate the T-wave effects in these studies to other measures of vagal tone and other biobehavioral mechanisms of coronary-prone behavior.

Four studies were conducted in normal young and middle-aged men and women selected as high and low on hostility, evaluating vagal tone measures and effects of isoproterenol infusion on EKG T-wave and ST response after pretreatment with saline, neostigmine, and atropine. Demonstration that hostility was associated with deficient vagal anatagonism of SNS effects on the heart, especially in middle-aged as compared to younger persons, suggested that diminished vagal tone was one pathway whereby high hostility contributed to increased CHD risk. Clinical studies were then conducted to determine whether weaker vagal tone predicted increased myocardial ischemia and/or poorer outcomes in coronary heart disease patients.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date March 1995
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (5)

Barefoot JC, Helms MJ, Mark DB, Blumenthal JA, Califf RM, Haney TL, O'Connor CM, Siegler IC, Williams RB. Depression and long-term mortality risk in patients with coronary artery disease. Am J Cardiol. 1996 Sep 15;78(6):613-7. — View Citation

Fukudo S, Lane JD, Anderson NB, Kuhn CM, Schanberg SM, McCown N, Muranaka M, Suzuki J, Williams RB Jr. Accentuated vagal antagonism of beta-adrenergic effects on ventricular repolarization. Evidence of weaker antagonism in hostile type A men. Circulation. 1992 Jun;85(6):2045-53. — View Citation

Williams RB. Hostility and heart disease: Williams et al. (1980). Adv Mind Body Med. 2001 Winter;17(1):52-5. — View Citation

Williams RB. Lower socioeconomic status and increased mortality: early childhood roots and the potential for successful interventions. JAMA. 1998 Jun 3;279(21):1745-6. — View Citation

Williams RB. The mind, the body, health, and disease. What do we know, what should we do? N C Med J. 1998 May-Jun;59(3):172-4. — View Citation

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