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

This study has been completed.
Sponsor:
Collaborators:
Nordic Institute of Chiropractic and Clinical Biomechanics
Odense University Hospital
University of Southern Denmark
The County of Funen, Denmark
Foundation for Chiropractic Research and Post Graduate Education
Information provided by (Responsible Party):
Mette Jensen Stochkendahl, Clinical Locomotion Science
ClinicalTrials.gov Identifier:
NCT00373828
First received: September 7, 2006
Last updated: February 19, 2013
Last verified: February 2013

September 7, 2006
February 19, 2013
June 2006
March 2008   (final data collection date for primary outcome measure)
Musculoskeletal chest pain [ Time Frame: baseline ] [ Designated as safety issue: No ]
Presence of MSCP yes/no
Not Provided
Complete list of historical versions of study NCT00373828 on ClinicalTrials.gov Archive Site
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Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis.
Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Three hundred consecutive patients with an episode of suspected non-cardiac acute chest pain will be recruited from among patients discharged from an acute chest pain clinic situated at a large specialized cardiology department.

  • Non-Cardiac Chest Pain
  • Undiagnosed Chest Pain
  • Musculoskeletal Chest Pain
  • Ischemic Heart Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00373828
Project 73 (NUA)
Not Provided
Mette Jensen Stochkendahl, Clinical Locomotion Science
Clinical Locomotion Science
  • Nordic Institute of Chiropractic and Clinical Biomechanics
  • Odense University Hospital
  • University of Southern Denmark
  • The County of Funen, Denmark
  • Foundation for Chiropractic Research and Post Graduate Education
Study Chair: Poul Flemming Hoilund-Carlsen, Professor The Dept. of Nuclear Medicine, Odense University Hospital
Study Chair: Torben Haghfelt, Professor The Dept. of Cardiology, Odense University Hospital
Clinical Locomotion Science
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP