Cardiac-CT in the Treatment of Acute Chest Pain (CATCH)
This study is ongoing, but not recruiting participants.
Sponsor:
Hvidovre University Hospital
Information provided by (Responsible Party):
Jens D Hove, MD,PHD, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01534000
First received: December 22, 2011
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
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 death, myocardial infarction, need for revascularisation, admittance for heart related problems, sustained chest pain, live quality score, use of medication.
| Condition | Intervention |
|---|---|
|
Ischemic Heart Disease |
Procedure: Cardiac computed tomographic angiography (CCTA) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Cardiac-CT in the Treatment of Acute Chest Pain |
Resource links provided by NLM:
Further study details as provided by Hvidovre University Hospital:
Primary Outcome Measures:
- combined endpoint of: death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- death [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
- myocardial infarction [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
- readmissions for chest pain [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
- Revascularisation [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
- unstabile angina [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
- continued chest pain [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
- Quality of life (SF-36) [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
- medication [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
- non-cardiac findings on CT [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
- downstream testing [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
Procedure: Cardiac computed tomographic angiography (CCTA)
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 Name: Adenosin for CT myocardial perfusion
|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jens D Hove, MD,PHD, Chief of Cardiac CT, MD,PHD, Hvidovre University Hospital |
| ClinicalTrials.gov Identifier: | NCT01534000 History of Changes |
| Other Study ID Numbers: | H-C-2009-053 |
| Study First Received: | December 22, 2011 |
| Last Updated: | April 1, 2013 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by Hvidovre University Hospital:
|
Cardiac CT Ischemic heat disease Stress test |
Additional relevant MeSH terms:
|
Chest Pain Coronary Artery Disease Myocardial Ischemia Heart Diseases Ischemia Pain Signs and Symptoms |
Coronary Disease Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013