CArdiac cT in the Treatment of Acute CHest Pain 2 - Myocardial CT Perfusion
NCT ID: NCT02014311
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
600 participants
INTERVENTIONAL
2013-10-31
2022-12-31
Brief Summary
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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
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\- 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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
CTA+CTP guided treatment strategy
CTA+CTP guided treatment strategy
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
CTA guided treatment strategy
CTA guided treatment strategy
Interventions
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CTA+CTP guided treatment strategy
CTA+CTP guided treatment strategy
CTA guided treatment strategy
CTA guided treatment strategy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Copenhagen University Hospital, Hvidovre
OTHER
Amager Hospital
OTHER
Bispebjerg Hospital
OTHER
Herlev Hospital
OTHER
Glostrup University Hospital, Copenhagen
OTHER
University Hospital, Gentofte, Copenhagen
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Klaus Fuglsang Kofoed
Associate Professor
Principal Investigators
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Klaus F Kofoed, MD, DmSc
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
Locations
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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
Copenhagen, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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H-3-2013-065
Identifier Type: -
Identifier Source: org_study_id