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
  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 Clinical Locomotion Science:

Primary Outcome Measures:
  • Musculoskeletal chest pain [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
Study First Received: September 7, 2006
Last Updated: February 19, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by 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:
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Pain
Signs and Symptoms
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014