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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Procedure: CTA+CTP guided treatment strategy
Procedure: CTA guided treatment strategy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Myocardial Perfusion 320 MDCT Guided Treatment Strategy for the Clinical Management of Patient With Recent Acute-onset Chest Pain. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 600
Study Start Date: October 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: CTA+CTP guided treatment strategy
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
Procedure: CTA guided treatment strategy
CTA guided treatment strategy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014311

Contacts
Contact: Klaus F Kofoed, MD, DmSc +45 35458569 kkofoed@dadlnet.dk

Locations
Denmark
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Klaus F Kofoed, MD, DmSc    +45 35458569    kkofoed@dadlnet.dk   
Sub-Investigator: Jesper J Linde, MD         
Department of Cardiology, Hvidovre University Hospital Recruiting
Copenhagen, Denmark, xxxx
Contact: Jens D Hove, MD, PhD       jhove@dadlnet.dk   
Principal Investigator: Jens D Hove, MD, PhD         
Department of Cardiology, Amager Hospital Recruiting
Copenhagen, Denmark
Contact: Jan Roland, MD         
Principal Investigator: Jan Roland, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Hvidovre University Hospital
Amager Hospital
Investigators
Principal Investigator: Klaus F Kofoed, MD, DmSc Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
  More Information

Additional Information:
Publications:
Responsible Party: Klaus Fuglsang Kofoed, Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02014311     History of Changes
Other Study ID Numbers: H-3-2013-065
Study First Received: December 12, 2013
Last Updated: December 17, 2013
Health Authority: Denmark: National Board of Health
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Multidetector Computed Tomography
Myocardial Perfusion Imaging
Coronary Stenosis
Coronary Artery Disease
Angina Pectoris

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Pain
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014