- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01534000
Cardiac-CT in the Treatment of Acute Chest Pain (CATCH)
Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a prospective randomized controlled trial designed to evaluate the clinical value of cardiac multidetector computed tomography (MDCT) as a first-line diagnostic strategy in patients with acute chest pain, compared to a conventional functional-based testing strategy.
Methods:
Consecutive patients admitted with acute chest pain of suspected cardiac origin, but normal electrocardiogram and biomarkers were randomized to evaluation with 320-MDCT coronary angiography (CT-guided group) or with standard bicycle exercise test and/or myocardial perfusion imaging - MPI (Control group).
After one year, patients will be followed-up, with registration of clinical endpoints such as Cardiac death, myocardial infarction, need for revascularisation, admittance for heart related problems, sustained chest pain, live quality score, use of medication.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hvidovre, Denmark, 2650
- Hvidovre University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Admittance because of Chest pain
- Non- or non-diagnostic ecg-changes.
- Normal biomarkers for ischemia (Troponins)
- Chest X-ray without pathological findings associated with chest pain.
Exclusion Criteria:
- Women of childbearing age, or > 40 years and using approved contraception.
- Claustrophobia
- Patients with geographical residence, that complicates follow-up
- Patients with mental or physical conditions that impede follow-up
- Increase in Troponins
- New diagnostic ECG changes with ST-segment elevation or depression greater than 1mm or T-yew inversion> 4 mm in> 2 anatomically connected derivations.
- Allergy to iodinated contrast agents
- Serum creatinine greater than 130 mg/l
- Abnormal chest x-ray or blood tests hospitalization as assessed as the main cause of the patient's pain problem.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: CT guided group
For Patients with chest pain randomised to this arm, clinical decision will be based on the results of a Cardiac computed tomographic angiography (CCTA)
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Patients will (on top of the standard clinical evaluation with a functional-based stress-test) be examined with a Cardiac CT scan.
In the control group, the Cardiac CT will be blinded for clinical evaluation and only used retrospectively for research purpose.
Other Names:
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No Intervention: Control group
Patients with chest pain randomised to the control group will be evaluated using the standard functional-based strategy with either a treadmill stress-test or SPECT (single-photon emission computed tomography).
A Cardiac CT will will be performed, but will be blinded for initial clinical evaluation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain
Time Frame: 1 year follow-up
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1 year follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Cardiac death
Time Frame: 1 year follow-up
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1 year follow-up
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myocardial infarction
Time Frame: 1 year follow-up
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1 year follow-up
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readmissions for chest pain
Time Frame: 1 year follow-up
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1 year follow-up
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Revascularisation
Time Frame: 1 year follow-up
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1 year follow-up
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unstabile angina
Time Frame: 1-year follow-up
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1-year follow-up
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continued chest pain
Time Frame: 1 year follow-up
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1 year follow-up
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Quality of life (SF-36)
Time Frame: 1-year follow-up
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1-year follow-up
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medication
Time Frame: 1-year follow-up
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1-year follow-up
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non-cardiac findings on CT
Time Frame: 1-year follow-up
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1-year follow-up
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downstream testing
Time Frame: 1-year follow-up
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1-year follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jesper J Linde, MD, Hvidovre University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-C-2009-053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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