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
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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
600
CTA+CTP guided treatment strategy
CTA guided treatment strategy
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
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
Time frame: Within 60 days of study inclusion
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
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
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