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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CTA+CTP guided treatment strategy
CTA guided treatment strategy
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Multidetector Computed Tomography, Myocardial Perfusion Imaging, Coronary Stenosis, Coronary Artery Disease, Angina Pectoris

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
  • Department of Cardiology, Amager University Hospital
  • Department of Cardiology, Bispebjerg University Hospital
  • Department of Cardiology, Gentofte University Hospital
  • Department of Cardiology, Glostrup University Hospital
  • Department of Cardiology, Herlev Hospital
  • Department of Cardiology, Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CTA+CTP guided treatment strategy

CTA guided treatment strategy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Frequency of coronary revascularization among included patients referred for invasive investigation
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
New referral for invasive investigation following inititial evaluation
Coronary revascularization - not including revascularization related to index evaluation
Invasive procedure related events
Among patients referred for invasive evaluation and treatment, procedure related events including death, bleeding, vascular complications, stroke and acute myocardial infarction will be recorded

Full Information

First Posted
December 12, 2013
Last Updated
December 9, 2022
Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen University Hospital, Hvidovre, Amager Hospital, Bispebjerg Hospital, Herlev Hospital, Glostrup University Hospital, Copenhagen, University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02014311
Brief Title
CArdiac cT in the Treatment of Acute CHest Pain 2 - Myocardial CT Perfusion
Acronym
CATCH2
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen University Hospital, Hvidovre, Amager Hospital, Bispebjerg Hospital, Herlev Hospital, Glostrup University Hospital, Copenhagen, University Hospital, Gentofte, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Multidetector Computed Tomography, Myocardial Perfusion Imaging, Coronary Stenosis, Coronary Artery Disease, Angina Pectoris

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTA+CTP guided treatment strategy
Arm Type
Experimental
Arm Description
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
Arm Title
CTA guided treatment strategy
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
CTA+CTP guided treatment strategy
Intervention Description
CTA+CTP guided treatment strategy
Intervention Type
Procedure
Intervention Name(s)
CTA guided treatment strategy
Intervention Description
CTA guided treatment strategy
Primary Outcome Measure Information:
Title
Frequency of coronary revascularization among included patients referred for invasive investigation
Description
Among patients referred for invasive coronary evaluation the frequency of subsequent PCI and/or CABG is recorded
Time Frame
Within 60 days of study inclusion
Secondary Outcome Measure Information:
Title
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
Title
New referral for invasive investigation following inititial evaluation
Time Frame
3, 12 and 24 months after CT examination
Title
Coronary revascularization - not including revascularization related to index evaluation
Time Frame
3, 12 and 24 months after CT examination
Title
Invasive procedure related events
Description
Among patients referred for invasive evaluation and treatment, procedure related events including death, bleeding, vascular complications, stroke and acute myocardial infarction will be recorded
Time Frame
Within 30 days of invasive procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recent acute-onset chest pain where coronary artery disease is suspected During initial acute hospitalization: Normal coronary biomarkers (Troponins) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus F Kofoed, MD, DmSc
Organizational Affiliation
Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Cardiology, Amager University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Cardiology, Bispebjerg University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Cardiology, Gentofte University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Cardiology, Glostrup University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Cardiology, Herlev Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Cardiology, Hvidovre University Hospital
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23998546
Citation
Linde JJ, Kofoed KF, Sorgaard M, Kelbaek H, Jensen GB, Nielsen WB, Hove JD. Cardiac computed tomography guided treatment strategy in patients with recent acute-onset chest pain: results from the randomised, controlled trial: CArdiac cT in the treatment of acute CHest pain (CATCH). Int J Cardiol. 2013 Oct 15;168(6):5257-62. doi: 10.1016/j.ijcard.2013.08.020. Epub 2013 Aug 14.
Results Reference
background
PubMed Identifier
22143171
Citation
Kuhl JT, Linde JJ, Fuchs A, Kristensen TS, Kelbaek H, George RT, Hove JD, Kofoed KF. Patterns of myocardial perfusion in humans evaluated with contrast-enhanced 320 multidetector computed tomography. Int J Cardiovasc Imaging. 2012 Oct;28(7):1739-47. doi: 10.1007/s10554-011-9986-z. Epub 2011 Dec 6.
Results Reference
background

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

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