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| Name | Class |
|---|---|
| Copenhagen University Hospital, Hvidovre | OTHER |
| Amager Hospital | OTHER |
| Bispebjerg Hospital | OTHER |
| Herlev Hospital |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTA+CTP guided treatment strategy | Experimental | 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 guided treatment strategy | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTA+CTP guided treatment strategy | Procedure | CTA+CTP guided treatment strategy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Recent acute-onset chest pain where coronary artery disease is suspected
During initial acute hospitalization:
Age ≥50 years
≥ 1 cardiovascular risk factor (family history of CAD, hypertension, hypercholesterolemia, diabetes, smoking) corresponding to a Duke clinical score ≥20%
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus F Kofoed, MD, DmSc | Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23998546 | Background | 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. | |
| 22143171 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Glostrup University Hospital, Copenhagen | OTHER |
| University Hospital, Gentofte, Copenhagen | OTHER |
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| CTA guided treatment strategy | Procedure | CTA guided treatment strategy |
|
| 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 |
| 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 |
| Background |
| 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |