Cardiac-CT in the Treatment of Acute Chest Pain (CATCH)

June 18, 2014 updated by: Jens D Hove, MD,PHD, Hvidovre University Hospital

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

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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)
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:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain
Time Frame: 1 year follow-up
1 year follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac death
Time Frame: 1 year follow-up
1 year follow-up
myocardial infarction
Time Frame: 1 year follow-up
1 year follow-up
readmissions for chest pain
Time Frame: 1 year follow-up
1 year follow-up
Revascularisation
Time Frame: 1 year follow-up
1 year follow-up
unstabile angina
Time Frame: 1-year follow-up
1-year follow-up
continued chest pain
Time Frame: 1 year follow-up
1 year follow-up
Quality of life (SF-36)
Time Frame: 1-year follow-up
1-year follow-up
medication
Time Frame: 1-year follow-up
1-year follow-up
non-cardiac findings on CT
Time Frame: 1-year follow-up
1-year follow-up
downstream testing
Time Frame: 1-year follow-up
1-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jesper J Linde, MD, Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

February 15, 2012

First Posted (Estimate)

February 16, 2012

Study Record Updates

Last Update Posted (Estimate)

June 19, 2014

Last Update Submitted That Met QC Criteria

June 18, 2014

Last Verified

June 1, 2014

More Information

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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