Cardiac Arrhythmias and the Perception of Symptoms

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005688
• Other study ID #: 4184
• Secondary ID: R01HL043216
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: March 15, 2016
• Start date: July 1989
• Est. completion date: February 1997

Study information

• Verified date: July 2000
• 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 investigate the differential diagnosis and longitudinal course of medical outpatients complaining of palpitations. Also, to further examine the process of cardiac perception, the psychological factors which influence it, and the accurate awareness of cardiac arrhythmias.

Description:

DESIGN NARRATIVE:

One hundred seventy-five consecutive patients referred for continuous ambulatory electrocardiographic (Holter) monitoring because of palpitations were studied. The investigators assessed cardiac symptoms, psychiatric diagnosis, life stress, beliefs about heart disease, somatization, and bodily absorption and amplification. Cardiac awareness, cardiac symptoms and cardiac activity were assessed during Holter monitoring and exercise tolerance testing (ETT). The referring physicians completed instruments rating their diagnostic impressions and clinical interventions. The patients' clinical course was then followed over the ensuing 12 months with telephone interviews and in-person assessments. These data permitted description and distinguished three subgroups of palpitation patients: those with panic disorder, in whom the symptom resulted from sympathetic nervous system arousal; those who were somatizing after a life event caused them to suspect that they had heart disease, in whom the palpitation resulted from a cognitive misattribution of benign bodily sensation; and those with clinically significant arrhythmias, whose symptoms resulted from a major cardiac irregularity. These findings were used to develop a clinical algorithm to aid in the differential diagnosis of palpitations and in identifying the patients most appropriate for Holter monitoring.

The patients' longitudinal course was followed to determine the predictors of continued somatization and chronicity, and to study their medical care by examining the referring physicians' diagnostic impressions and interventions. By comparing cardiac symptoms with concurrent cardiac activity during Holter monitoring and ETT, the investigators hoped to develop measures of cardiac awareness. They would then be able to describe inter-individual differences in cardiac awareness, examine several psychological factors which amplify or modulate awareness, and investigate the relationship between somatization and accuracy of symptom reporting. It was hoped that the findings would ultimately lead to improved cognitive and educational techniques to reassure and palliate palpitation patients, and to the early identification of patients who were unlikely to obtain symptomatic relief from antiarrhythmic therapy.

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: February 1997
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Arrhythmia
• Cardiovascular Diseases
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

References & Publications (14)

Barsky AJ, Ahern DK, Bailey ED, Delamater BA. Predictors of persistent palpitations and continued medical utilization. J Fam Pract. 1996 May;42(5):465-72. — View Citation

Barsky AJ, Ahern DK, Brener J, Surman OS, Ring C, Dec GW. Palpitations and cardiac awareness after heart transplantation. Psychosom Med. 1998 Sep-Oct;60(5):557-62. — View Citation

Barsky AJ, Ahern DK, Delamater BA, Clancy SA, Bailey ED. Differential diagnosis of palpitations. Preliminary development of a screening instrument. Arch Fam Med. 1997 May-Jun;6(3):241-5. — View Citation

Barsky AJ, Borus JF. Somatization and medicalization in the era of managed care. JAMA. 1995 Dec 27;274(24):1931-4. — View Citation

Barsky AJ, Cleary PD, Barnett MC, Christiansen CL, Ruskin JN. The accuracy of symptom reporting by patients complaining of palpitations. Am J Med. 1994 Sep;97(3):214-21. — View Citation

Barsky AJ, Cleary PD, Brener J, Ruskin JN. The perception of cardiac activity in medical outpatients. Cardiology. 1993;83(5-6):304-15. — View Citation

Barsky AJ, Cleary PD, Coeytaux RR, Ruskin JN. Psychiatric disorders in medical outpatients complaining of palpitations. J Gen Intern Med. 1994 Jun;9(6):306-13. — View Citation

Barsky AJ, Cleary PD, Coeytaux RR, Ruskin JN. The clinical course of palpitations in medical outpatients. Arch Intern Med. 1995 Sep 11;155(16):1782-8. — View Citation

Barsky AJ, Cleary PD, Sarnie MK, Ruskin JN. Panic disorder, palpitations, and the awareness of cardiac activity. J Nerv Ment Dis. 1994 Feb;182(2):63-71. — View Citation

Barsky AJ, Delamater BA, Clancy SA, Antman EM, Ahern DK. Somatized psychiatric disorder presenting as palpitations. Arch Intern Med. 1996 May 27;156(10):1102-8. — View Citation

Barsky AJ, Orav JE, Delamater BA, Clancy SA, Hartley LH. Cardiorespiratory symptoms in response to physiological arousal. Psychosom Med. 1998 Sep-Oct;60(5):604-9. — View Citation

Barsky AJ. A research agenda for outpatient consultation-liaison psychiatry. Gen Hosp Psychiatry. 1993 Nov;15(6):381-5. — View Citation

Barsky AJ. Palpitations, cardiac awareness, and panic disorder. Am J Med. 1992 Jan 24;92(1A):31S-34S. — View Citation

Brown HD, Kosslyn SM, Delamater B, Fama J, Barsky AJ. Perceptual and memory biases for health-related information in hypochondriacal individuals. J Psychosom Res. 1999 Jul;47(1):67-78. — View Citation

* Note: There are 14 references in all — Click here to view all references