NCT00373828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

September 7, 2006

Last Update Submit

February 19, 2013

Conditions

Non-Cardiac Chest PainUndiagnosed Chest PainMusculoskeletal Chest PainIschemic Heart Disease

Keywords

Chest PainChest WallAngina PectorisAtypical Chest PainPhysical ExaminationMyocardial Perfusion ImagingObservational StudyNon-Cardiac Chest PainIschemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Musculoskeletal chest pain

    Presence of MSCP yes/no

    baseline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Dept. of Cardiology and Dept. of Nuclear Medicine, Odense University Hospital

Sdr. Boulevard 29, Odense C, DK-5000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 18377636BACKGROUND

  • 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.

    PMID: 22377444RESULT

Related Links

MeSH Terms

Conditions

Myocardial IschemiaChest PainAngina Pectoris

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DC, PhD

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 8, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

DK(1)