Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis.
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 7, 2006 | ||||||||
| Last Updated Date | February 19, 2013 | ||||||||
| Start Date ICMJE | June 2006 | ||||||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Musculoskeletal chest pain [ Time Frame: baseline ] [ Designated as safety issue: No ] Presence of MSCP yes/no |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00373828 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis. | ||||||||
| Official Title ICMJE | Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 302 | ||||||||
| Completion Date | March 2008 | ||||||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00373828 | ||||||||
| Other Study ID Numbers ICMJE | Project 73 (NUA) | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Mette Jensen Stochkendahl, Clinical Locomotion Science | ||||||||
| Study Sponsor ICMJE | Clinical Locomotion Science | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Clinical Locomotion Science | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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