Cardiovascular DiseasesNCT00005688
Cardiac Arrhythmias and the Perception of Symptoms
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Arrhythmia
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1989to Feb 1997
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Arrhythmia
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Arrhythmias, Cardiac
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 1989
- Study completionFeb 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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 National Heart, Lung, and Blood Institute (NHLBI)The 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
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005688
- Sponsor's protocol ID
- 4184
- Other IDs
- R01HL043216
- Status last verified
- Jul 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
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.
PubMed 8112561Barsky 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.
PubMed 8111763Barsky 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.
PubMed 7654112Barsky 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.
PubMed 9161349Barsky AJ, Ahern DK, Bailey ED, Delamater BA. Predictors of persistent palpitations and continued medical utilization. J Fam Pract. 1996 May;42(5):465-72.
PubMed 8642363Barsky 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.
PubMed 8638998Barsky 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.
PubMed 1734732Barsky 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.
PubMed 8092169Barsky 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.
PubMed 8077994Barsky 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.
PubMed 8308534Brown 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.
PubMed 10511422Barsky 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.
PubMed 9773765Barsky 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.
PubMed 9773758Barsky AJ, Borus JF. Somatization and medicalization in the era of managed care. JAMA. 1995 Dec 27;274(24):1931-4.
PubMed 8568987
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Arrhythmias and the Perception of Symptoms
- ClinicalTrials.gov ID
- NCT00005688
- Acronym / sponsor ID
- 4184
- Conditions
- Cardiovascular Diseases, Heart Diseases, Arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1989
- Study completion
- Feb 1997 (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 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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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 16 Mar 2016.
- Background: PubMed 8112561Barsky 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.
- Background: PubMed 8111763Barsky 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.
- Background: PubMed 7654112Barsky 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.
- Background: PubMed 9161349Barsky 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.
- Background: PubMed 8642363Barsky AJ, Ahern DK, Bailey ED, Delamater BA. Predictors of persistent palpitations and continued medical utilization. J Fam Pract. 1996 May;42(5):465-72.
- Background: PubMed 8638998Barsky 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.
- Background: PubMed 1734732Barsky 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.
- Background: PubMed 8092169Barsky 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.
- Background: PubMed 8077994Barsky 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.
- Background: PubMed 8308534Barsky 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.
- Background: PubMed 10511422Brown 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.
- Background: PubMed 9773765Barsky 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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 16 Mar 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 NCT00005688, which also lists 14 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 16 Mar 2016.