Non-Cardiac Chest PainNCT00373828
Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis.
An observational study of Non-Cardiac Chest Pain and Undiagnosed Chest Pain, run by Clinical Locomotion Science at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Cardiac Chest Pain, Undiagnosed Chest Pain, Musculoskeletal Chest Pain
- How many people
- 302 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2006to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Dept. of Cardiology and Dept. of Nuclear Medicine, Odense University Hospital
Sdr. Boulevard 29, Odense C, DK-5000
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-Cardiac Chest Pain, Undiagnosed Chest Pain, Musculoskeletal Chest Pain, Ischemic Heart Disease
- Keywords
- Chest Pain, Chest Wall, Angina Pectoris, Atypical Chest Pain, Physical Examination, Myocardial Perfusion Imaging, Observational Study, Non-Cardiac Chest Pain, Ischemic Heart Disease
- Medical subject headings
- Myocardial Ischemia, Chest Pain, Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal chest pain
Presence of MSCP yes/no
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Cardiac Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Locomotion Science
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Mette Jensen Stochkendahl, Clinical Locomotion Science
- Investigators
- Poul Flemming Hoilund-Carlsen, Professor, Study chair, The Dept. of Nuclear Medicine, Odense University HospitalTorben Haghfelt, Professor, Study chair, The Dept. of Cardiology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373828
- Sponsor's protocol ID
- Project 73 (NUA)
- Status last verified
- Feb 2013
- First submitted
- 7 Sep 2006
- Last updated
- 20 Feb 2013
- Results posted
- No
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.
PubMed 18377636Stochkendahl 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.
PubMed 22377444
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis
- ClinicalTrials.gov ID
- NCT00373828
- Acronym / sponsor ID
- Project 73 (NUA)
- Conditions
- Non-Cardiac Chest Pain, Undiagnosed Chest Pain, Musculoskeletal Chest Pain, Ischemic Heart Disease
- Keywords
- Chest Pain, Chest Wall, Angina Pectoris, Atypical Chest Pain, Physical Examination, Myocardial Perfusion Imaging, Observational Study, Non-Cardiac Chest Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Clinical Locomotion ScienceUniversity, hospital or other
- 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
- Study start
- Jun 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Musculoskeletal chest pain
Time frame: baseline
Presence of MSCP yes/no
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Background: PubMed 18377636Stochkendahl 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.
- Results publication: PubMed 22377444Stochkendahl 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poul Flemming Hoilund-Carlsen, Professor study chair
The Dept. of Nuclear Medicine, Odense University Hospital
Torben Haghfelt, Professor study chair
The Dept. of Cardiology, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Cardiac Chest Pain and Undiagnosed Chest Pain, run by Clinical Locomotion Science at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal chest pain (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00373828, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.