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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373828
First Posted: September 8, 2006
Last Update Posted: February 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis

Resource links provided by NLM:


Further study details as provided by Mette Jensen Stochkendahl, Clinical Locomotion Science:

Primary Outcome Measures:
  • Musculoskeletal chest pain [ Time Frame: baseline ]
    Presence of MSCP yes/no


Enrollment: 302
Study Start Date: June 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373828


Locations
Denmark
The Dept. of Cardiology and Dept. of Nuclear Medicine, Odense University Hospital
Sdr. Boulevard 29, Odense C, Denmark, DK-5000
Sponsors and Collaborators
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
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Mette Jensen Stochkendahl, DC, PhD, Clinical Locomotion Science
ClinicalTrials.gov Identifier: NCT00373828     History of Changes
Other Study ID Numbers: Project 73 (NUA)
First Submitted: September 7, 2006
First Posted: September 8, 2006
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Mette Jensen Stochkendahl, Clinical Locomotion Science:
Chest Pain
Chest Wall
Angina Pectoris
Atypical Chest Pain
Physical Examination
Myocardial Perfusion Imaging
Observational Study
Non-Cardiac Chest Pain
Ischemic Heart Disease

Additional relevant MeSH terms:
Heart Diseases
Chest Pain
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases