CArdiac cT in the Treatment of Acute CHest Pain 2 - Myocardial CT Perfusion (CATCH2)

This study is currently recruiting participants.
Verified December 2013 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
Hvidovre University Hospital
Amager Hospital
Information provided by (Responsible Party):
Klaus Fuglsang Kofoed, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02014311
First received: December 12, 2013
Last updated: December 17, 2013
Last verified: December 2013

December 12, 2013
December 17, 2013
October 2013
May 2016   (final data collection date for primary outcome measure)
Frequency of coronary revascularization among included patients referred for invasive investigation [ Time Frame: Within 60 days of study inclusion ] [ Designated as safety issue: No ]
Among patients referred for invasive coronary evaluation the frequency of subsequent PCI and/or CABG is recorded
Same as current
Complete list of historical versions of study NCT02014311 on ClinicalTrials.gov Archive Site
  • Hospital admittance due to recurrence of chest pain, acute myocardial infarction or cardiac death [ Time Frame: Within 3, 12 and 24 months after CT examination ] [ Designated as safety issue: Yes ]
  • New referral for invasive investigation following inititial evaluation [ Time Frame: 3, 12 and 24 months after CT examination ] [ Designated as safety issue: Yes ]
  • Coronary revascularization - not including revascularization related to index evaluation [ Time Frame: 3, 12 and 24 months after CT examination ] [ Designated as safety issue: Yes ]
  • Invasive procedure related events [ Time Frame: Within 30 days of invasive procedure ] [ Designated as safety issue: Yes ]
    Among patients referred for invasive evaluation and treatment, procedure related events including death, bleeding, vascular complications, stroke and acute myocardial infarction will be recorded
Same as current
Not Provided
Not Provided
 
CArdiac cT in the Treatment of Acute CHest Pain 2 - Myocardial CT Perfusion
Myocardial Perfusion 320 MDCT Guided Treatment Strategy for the Clinical Management of Patient With Recent Acute-onset Chest Pain. A Randomized Controlled Trial

The aim of this study is to assess whether the clinical management of patients with recent acute-onset chest pain without acute coronary syndrome may be optimized by a combined coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for invasive testing will be performed within 2 weeks after hospital discharge.

The following main hypothesis will be tested:

- Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in a safe and optimized, cost-effective invasive treatment strategy

MATERIAL

- Consecutive patients referred with chest pain in whom acute coronary syndrome has been excluded, yet with a maintained clinical suspicion of coronary artery disease will be included in the study. Only patients deemed clinically suited for subsequent invasive evaluation and treatment will be included.

METHODS

-If the patients accept participation in the trial a computerized 1:1 randomization for CTA alone (control group) or CTA and CTP combined (intervention group) within 2 weeks from discharge will be conducted. CT angiography and CT myocardial perfusion imaging will be performed using a 320-slice MSCT Toshiba VISION Edition Aquilion One scanner according to recommendations from the vendor and clinical routine developed at Rigshospitalet. Based on CTA and/or CTP findings patients will be referred for invasive evaluation including fractional flow reserve assessment (FFR) and treatment within 30 days. Invasive procedures will be performed according to international guidelines and the frequency of revascularization procedures recorded. Clinical outcome data according to specified secondary endpoints will be recorded from hospital charts and medical registries.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
  • Procedure: CTA+CTP guided treatment strategy
    CTA+CTP guided treatment strategy
  • Procedure: CTA guided treatment strategy
    CTA guided treatment strategy
  • Experimental: CTA+CTP guided treatment strategy
    Patients with adenosine stress induced regional myocardial hypoperfusion (CT perfusion imaging) in combination with a corresponding epicardial coronary vessel with >50% stenosis (Coronary CT angiography) will be referred for invasive investigation within 30 days after study inclusion - CTP-INTERVENTION
    Intervention: Procedure: CTA+CTP guided treatment strategy
  • Active Comparator: CTA guided treatment strategy
    Patients with at least one epicardial coronary artery stenosis >50% (Coronary CT angiography) will be referred for invasive investigation within 30 days after initial discharge from the hospital - CONTROL
    Intervention: Procedure: CTA guided treatment strategy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
June 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Recent acute-onset chest pain where coronary artery disease is suspected
  • During initial acute hospitalization:

    1. Normal coronary biomarkers (Troponins)
    2. No or non-diagnostic ECG changes (LV hypertrophy, bundle branch blok, pacemaker rhythm)
  • Age ≥50 years
  • ≥ 1 cardiovascular risk factor (family history of CAD, hypertension, hypercholesterolemia, diabetes, smoking) corresponding to a Duke clinical score ≥20%

Exclusion Criteria:

  • Known Iodine contrast allergy
  • Estimated GFR below 50 ml/min
  • Adenosine intolerance - known allergic asthma
  • Previous CABG
  • Patient related circumstances which preclude informed consent from the patient
  • Patients in whom psychiatric, physical or geographic conditions do not allow long-term clinical followup
  • Expected survival of less that 2 years
Both
50 Years and older
No
Contact: Klaus F Kofoed, MD, DmSc +45 35458569 kkofoed@dadlnet.dk
Denmark
 
NCT02014311
H-3-2013-065
No
Klaus Fuglsang Kofoed, Rigshospitalet, Denmark
Rigshospitalet, Denmark
  • Hvidovre University Hospital
  • Amager Hospital
Principal Investigator: Klaus F Kofoed, MD, DmSc Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
Rigshospitalet, Denmark
December 2013

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