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Cardiac Arrhythmias and the Perception of Symptoms

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Arrhythmia

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005688
    Brief Title
    Cardiac Arrhythmias and the Perception of Symptoms
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    July 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1989 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 1997 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Arrhythmia

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    8112561
    Citation
    Barsky AJ. A research agenda for outpatient consultation-liaison psychiatry. Gen Hosp Psychiatry. 1993 Nov;15(6):381-5. doi: 10.1016/0163-8343(93)90006-a.
    Results Reference
    background
    PubMed Identifier
    8111763
    Citation
    Barsky AJ, Cleary PD, Brener J, Ruskin JN. The perception of cardiac activity in medical outpatients. Cardiology. 1993;83(5-6):304-15. doi: 10.1159/000175986.
    Results Reference
    background
    PubMed Identifier
    7654112
    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.
    Results Reference
    background
    PubMed Identifier
    9161349
    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. doi: 10.1001/archfami.6.3.241.
    Results Reference
    background
    PubMed Identifier
    8642363
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8638998
    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.
    Results Reference
    background
    PubMed Identifier
    1734732
    Citation
    Barsky AJ. Palpitations, cardiac awareness, and panic disorder. Am J Med. 1992 Jan 24;92(1A):31S-34S. doi: 10.1016/0002-9343(92)90134-w.
    Results Reference
    background
    PubMed Identifier
    8092169
    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. doi: 10.1016/0002-9343(94)90003-5.
    Results Reference
    background
    PubMed Identifier
    8077994
    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. doi: 10.1007/BF02599176.
    Results Reference
    background
    PubMed Identifier
    8308534
    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. doi: 10.1097/00005053-199402000-00001.
    Results Reference
    background
    PubMed Identifier
    10511422
    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. doi: 10.1016/s0022-3999(99)00011-2.
    Results Reference
    background
    PubMed Identifier
    9773765
    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. doi: 10.1097/00006842-199809000-00016.
    Results Reference
    background
    PubMed Identifier
    9773758
    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. doi: 10.1097/00006842-199809000-00007.
    Results Reference
    background
    PubMed Identifier
    8568987
    Citation
    Barsky AJ, Borus JF. Somatization and medicalization in the era of managed care. JAMA. 1995 Dec 27;274(24):1931-4.
    Results Reference
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    Cardiac Arrhythmias and the Perception of Symptoms

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