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

This study is ongoing, but not recruiting participants.
Sponsor:
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

December 22, 2011
April 1, 2013
January 2010
January 2014   (final data collection date for primary outcome measure)
combined endpoint of: death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01534000 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cardiac-CT in the Treatment of Acute Chest Pain
Cardiac-CT in the Treatment of Acute Chest Pain

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Ischemic Heart Disease
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
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01534000
H-C-2009-053
No
Jens D Hove, MD,PHD, Hvidovre University Hospital
Hvidovre University Hospital
Not Provided
Study Director: Jesper J Linde, MD Hvidovre University Hospital
Hvidovre University Hospital
April 2013

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