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.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease; Non-Cardiac Chest Pain; Undiagnosed Chest Pain; Musculoskeletal Chest Pain

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.

• Study Type: Observational
• Enrollment (Actual): 302

Contacts and Locations

Study Locations

• Denmark
  • Odense C
    • Sdr. Boulevard 29, Odense C, Denmark, DK-5000
      • The Dept. of Cardiology and Dept. of Nuclear Medicine, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Musculoskeletal chest pain	Presence of MSCP yes/no	baseline

Collaborators and Investigators

• Sponsor: Clinical Locomotion Science
• Collaborators: Odense University Hospital; University of Southern Denmark; The County of Funen, Denmark; Nordic Institute of Chiropractic and Clinical Biomechanics; 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

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: September 7, 2006
• First Submitted That Met QC Criteria: September 7, 2006
• First Posted (Estimate): September 8, 2006

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 19, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Ischemic Heart Disease; Physical Examination; Observational Study; Myocardial Perfusion Imaging; Chest Pain; Angina Pectoris; Chest Wall; Atypical Chest Pain; Non-Cardiac Chest Pain
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Chest Pain
• Other Study ID Numbers: Project 73 (NUA)