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Trial record 1 of 1 for:    NCT01534000
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Cardiac-CT in the Treatment of Acute Chest Pain (CATCH)

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

Tracking Information
First Submitted Date  ICMJE December 22, 2011
First Posted Date  ICMJE February 16, 2012
Last Update Posted Date June 19, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: February 15, 2012)
combined endpoint of: death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain [ Time Frame: 1 year follow-up ]
Change History Complete list of historical versions of study NCT01534000 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Cardiac-CT in the Treatment of Acute Chest Pain
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Ischemic Heart Disease
Intervention  ICMJE 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  ICMJE
  • 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, Sørgaard M, Kelbæk H, Jensen GB, Kühl JT, Hindsø L, Køber 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2012)
600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01534000
Other Study ID Numbers  ICMJE H-C-2009-053
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jens D Hove, MD,PHD, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jesper J Linde, MD Hvidovre University Hospital
PRS Account Hvidovre University Hospital
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP