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

December 9, 2022 updated by: Klaus Fuglsang Kofoed, Rigshospitalet, Denmark

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
      • Copenhagen, Denmark
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 60 days of study inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
Within 30 days of invasive procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Bispebjerg Hospital
Herlev Hospital
Glostrup University Hospital, Copenhagen
Amager Hospital
University Hospital, Gentofte, Copenhagen
Copenhagen University Hospital, Hvidovre

Investigators

  • Principal Investigator: Klaus F Kofoed, MD, DmSc, Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 18, 2013

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2013-065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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