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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Myocardial Perfusion 320 MDCT Guided Treatment Strategy for the Clinical Management of Patient With Recent Acute-onset Chest Pain. A Randomized Controlled Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: CTA+CTP guided treatment strategy
* Procedure: CTA guided treatment strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTA+CTP guided treatment strategy<br>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<br>* CTA+CTP guided treatment strategy<br>|
| Active Comparator: CTA guided treatment strategy<br>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<br>* CTA guided treatment strategy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 |  | Within 3, 12 and 24 months after CT examination | 
| New referral for invasive investigation following inititial evaluation |  | 3, 12 and 24 months after CT examination | 
| Coronary revascularization - not including revascularization related to index evaluation |  | 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 | Within 30 days of invasive procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multidetector Computed Tomography, Myocardial Perfusion Imaging, Coronary Stenosis, Coronary Artery Disease, Angina Pectoris