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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02014311
First Posted: December 18, 2013
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Copenhagen University Hospital, Hvidovre
Amager Hospital
Bispebjerg Hospital
Herlev Hospital
Glostrup University Hospital, Copenhagen
University Hospital, Gentofte, Copenhagen
Information provided by (Responsible Party):
Klaus Fuglsang Kofoed, Rigshospitalet, Denmark
  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
Coronary Artery Disease Procedure: CTA+CTP guided treatment strategy Procedure: CTA guided treatment strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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 Klaus Fuglsang Kofoed, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Frequency of coronary revascularization among included patients referred for invasive investigation [ Time Frame: Within 60 days of study inclusion ]
    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 ]
  • New referral for invasive investigation following inititial evaluation [ Time Frame: 3, 12 and 24 months after CT examination ]
  • Coronary revascularization - not including revascularization related to index evaluation [ Time Frame: 3, 12 and 24 months after CT examination ]
  • Invasive procedure related events [ Time Frame: Within 30 days of invasive procedure ]
    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 2018
Primary Completion Date: March 2017 (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

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014311


Locations
Denmark
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, Denmark, 2100
Department of Cardiology, Amager University Hospital
Copenhagen, Denmark
Department of Cardiology, Bispebjerg University Hospital
Copenhagen, Denmark
Department of Cardiology, Gentofte University Hospital
Copenhagen, Denmark
Department of Cardiology, Glostrup University Hospital
Copenhagen, Denmark
Department of Cardiology, Herlev Hospital
Copenhagen, Denmark
Department of Cardiology, Hvidovre University Hospital
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen University Hospital, Hvidovre
Amager Hospital
Bispebjerg Hospital
Herlev Hospital
Glostrup University Hospital, Copenhagen
University Hospital, Gentofte, Copenhagen
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

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
First Submitted: December 12, 2013
First Posted: December 18, 2013
Last Update Posted: April 12, 2017
Last Verified: April 2017

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

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