Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis.

NCT ID: NCT00373828

Last Updated: 2013-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-03-31

Brief Summary

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The overall aim of the project is to evaluate diagnosis and treatment of chest pain originating from the musculoskeletal system. Specifically, we wish to investigate prevalence and character of such chest pain in a population of patients with acute chest pain, admitted to a university hospital based acute chest pain clinic, and undergoing evaluation of acute coronary syndrome (Part 1). Then, to test a manually-based treatment protocol to patients with diagnosed musculoskeletal chest pain in a randomized clinical trial (Part 2).

The specific purpose of this study (Part 1) is to determine the exact number of patients with acute chest pain origination from the musculoskeletal system, and to describe their cardiac status with respect to ischemic heart disease. Further, we wish to evaluate the decision making process of the chiropractor.

Detailed Description

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Acute chest pain is a common reason for hospital admission. The focus of diagnosis is of course pain of cardiac origin including myocardial infarction and/or other ischemic heart disease; however, in up to 50% of cases the aetiology may be non-cardiac. Differential diagnoses include primarily pulmonary, gastrointestinal, psychosocial, or musculoskeletal problems, and musculoskeletal problems may account for around 20% of the total number of admissions in acute chest pain clinics. Thus the musculoskeletal system is a recognized possible source of pain in patients with chest pain even though a confident diagnosis of musculoskeletal chest pain can be difficult to establish since no gold standard exists to verify this diagnosis.

Chest pain patients with normal coronary anatomy have an excellent prognosis for survival and a future risk of cardiac morbidity similar to that reported in the background population. However, about three quarters of patients with non-cardiac chest pain continue to suffer from residual chest pain with large socio-economic consequences. Therefore, a search for an alternative cause with related possibilities for treatment is warranted. Given these perspectives, the general objective of the present work is to study the diagnosis of chest pain originating from the musculoskeletal system of the cervical and thoracic spine, and thorax in patients with chest pain of various origins, and to evaluate ischemic heart disease status among patients with presumed musculoskeletal pain.

Evaluation:

Patients with musculoskeletal chest pain will be identified using a standardized examination protocol comprised of a semi-structured interview, a general health examination, and a specific manual examination of the muscles and joints of the neck, thoracic spine and thorax. All patients will have a Myocardial Perfusion Imaging (MPI) performed and results from the MPI will be compared with the musculoskeletal status. Specific important parameters of the standardized examination protocol will be identified and the decision making process of the chiropractor will be evaluated.

Conditions

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Non-Cardiac Chest Pain Undiagnosed Chest Pain Musculoskeletal Chest Pain Ischemic Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Acute episode of chest pain of less than 7 days duration as primary reason for admission to a chest pain clinic.
* Admitted to a chest pain clinic, suspected of acute coronary infarction, but with a negative diagnosis confirmed by normal coronary enzymes and normal ECG.
* Pain arising from the thorax and/or neck.
* Able to read and understand Danish.

Exclusion Criteria

* Acute coronary syndrome.
* Percutaneous Coronary Intervention.
* Coronary Artery Bypass Grafting.
* Other disease, diagnosed during this admission, which is likely to have caused the acute episode of chest pain.
* No written consent.
* Inflammatory joint disease.
* Diabetes mellitus, type I.
* Fibromyalgia.
* Sharp trauma to the chest.
* Malignant disease.
* Apoplexy.
* Gross osseous anomalies, such as pronounced scoliosis.
* Known or suspected osteoporosis.
* Pregnancy.
* Dementia/unable to cooperate.
* Not residing in the County of Funen.
* Does not want to participate.
* Other - reason for exclusion will be noted.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordic Institute of Chiropractic and Clinical Biomechanics

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

The County of Funen, Denmark

OTHER_GOV

Sponsor Role collaborator

Foundation for Chiropractic Research and Post Graduate Education

OTHER

Sponsor Role collaborator

Clinical Locomotion Science

OTHER

Sponsor Role lead

Responsible Party

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Mette Jensen Stochkendahl

DC, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Poul Flemming Hoilund-Carlsen, Professor

Role: STUDY_CHAIR

The Dept. of Nuclear Medicine, Odense University Hospital

Torben Haghfelt, Professor

Role: STUDY_CHAIR

The Dept. of Cardiology, Odense University Hospital

Locations

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The Dept. of Cardiology and Dept. of Nuclear Medicine, Odense University Hospital

Sdr. Boulevard 29, Odense C, Denmark

Site Status

Countries

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Denmark

References

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Stochkendahl MJ, Christensen HW, Vach W, Hoilund-Carlsen PF, Haghfelt T, Hartvigsen J. Diagnosis and treatment of musculoskeletal chest pain: design of a multi-purpose trial. BMC Musculoskelet Disord. 2008 Mar 31;9:40. doi: 10.1186/1471-2474-9-40.

Reference Type BACKGROUND
PMID: 18377636 (View on PubMed)

Stochkendahl MJ, Vach W, Hartvigsen J, Hoilund-Carlsen PF, Haghfelt T, Christensen HW. Reconstruction of the decision-making process in assessing musculoskeletal chest pain: an exploratory study using recursive partitioning. J Manipulative Physiol Ther. 2012 Mar-Apr;35(3):184-95. doi: 10.1016/j.jmpt.2012.01.009. Epub 2012 Feb 27.

Reference Type RESULT
PMID: 22377444 (View on PubMed)

Related Links

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Other Identifiers

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Project 73 (NUA)

Identifier Type: -

Identifier Source: org_study_id

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