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

• ClinicalTrials.gov Identifier: NCT01534000
• Recruitment Status: Completed
• First Posted: February 16, 2012
• Last Update Posted: June 19, 2014
• Sponsor: Hvidovre University Hospital
• Information provided by (Responsible Party): Jens D Hove, MD,PHD, Hvidovre University Hospital

Tracking Information

• First Submitted Date: December 22, 2011
• First Posted Date: February 16, 2012
• Last Update Posted Date: June 19, 2014
• Study Start Date: January 2010
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 18, 2014): combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain [ Time Frame: 1 year follow-up ]
• Original Primary Outcome Measures (submitted: February 15, 2012): combined endpoint of: death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain [ Time Frame: 1 year follow-up ]

Current Secondary Outcome Measures (submitted: June 18, 2014)

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

Original Secondary Outcome Measures (submitted: February 15, 2012)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cardiac-CT in the Treatment of Acute Chest Pain
• Official Title: Cardiac-CT in the Treatment of Acute Chest Pain

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Ischemic Heart Disease

Intervention

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

Study Arms

• 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)
  Intervention: Procedure: Cardiac computed tomographic angiography (CCTA)
• 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.

• Publications *: Linde JJ, Hove JD, Sorgaard M, Kelbaek H, Jensen GB, Kuhl JT, Hindso L, Kober L, Nielsen WB, Kofoed KF. Long-Term Clinical Impact of Coronary CT Angiography in Patients With Recent Acute-Onset Chest Pain: The Randomized Controlled CATCH Trial. JACC Cardiovasc Imaging. 2015 Dec;8(12):1404-1413. doi: 10.1016/j.jcmg.2015.07.015. Epub 2015 Nov 11.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 15, 2012): 600
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01534000
• Other Study ID Numbers: H-C-2009-053
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jens D Hove, MD,PHD, Hvidovre University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Hvidovre University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Hvidovre University Hospital
• Verification Date: June 2014