Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.

Study Overview
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Brief Summary
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This is a cross-sectional pilot study to assess coronary artery disease with minimal invasive techniques in patients with asymptomatic troponin elevation after noncardiac surgery. The primary objective is to quantify coronary artery disease, as determined by coronary CT and MR, as a cause of postoperative myocardial injury. The secondary objective is to correlate coronary calciumscore to postoperative levels of troponin.

Official Title
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Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.

Conditions
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Myocardium; Injury, Coronary Artery Disease

Intervention / Treatment
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* Other: Minimal invasive cardiac imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major noncardiac surgery with a planned minimal postoperative hospital stay of 2 days Age > 59 years Troponin_I elevation > 0.06 ng/ml in the first 3 post-operative days No clinical symptoms of myocardial ischemia Exclusion Criteria: Perioperative troponin elevation due to other factors than coronary artery disease such as proven pulmonary embolism or sepsis Perioperative ST-elevation myocardial infarction (STEMI) Perioperative symptomatic angina with troponin elevation Patients with a history or ECG-signs of myocardial infarction Patients with pre-existent heart failure, left ventricular dysfunction, significant valvular disease or left ventricle hypertrophy Patients with significant valvular disease or left ventricle hypertrophy determined postoperatively with echocardiography. Contra-indication for CMR such as claustrophobia or metal prosthesis Allergic reaction to CT-contrast or gadolinium Renal dysfunction with GFR < 50 ml/min, as determined after the operation Unstable hemodynamics or other conditions disabling transport to the Radiology department Expected major discomfort or substantial increase in pain sensation by undergoing CCTA or CMR Admission at the ICU Poor prognosis due to other medical conditions e.g. malignancy

Ages Eligible for Study
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Minimum Age: 60 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. TnI elevation<br>TnI 0.06-0.60ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging | Other: Minimal invasive cardiac imaging<br>* Coronary CT angiography (CCTA) Coronary magnetic resonance imaging (CMR) Echocardiography<br>|
| Experimental: 2. TnI elevation<br>TnI 0.61-6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging | Other: Minimal invasive cardiac imaging<br>* Coronary CT angiography (CCTA) Coronary magnetic resonance imaging (CMR) Echocardiography<br>|
| Experimental: 3. TnI elevation<br>TnI>6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging | Other: Minimal invasive cardiac imaging<br>* Coronary CT angiography (CCTA) Coronary magnetic resonance imaging (CMR) Echocardiography<br>|
| Experimental: 4. TnI elevation<br>TnI >6.00 ng/ml, ischemia on ECG and Hb<5.1. Intervention: minimal invasive cardiac imaging | Other: Minimal invasive cardiac imaging<br>* Coronary CT angiography (CCTA) Coronary magnetic resonance imaging (CMR) Echocardiography<br>|
| Experimental: 5. TnI elevation<br>TnI >6.00 ng/ml, ischemia on ECG and Hb>5.0. Intervention: minimal invasive cardiac imaging | Other: Minimal invasive cardiac imaging<br>* Coronary CT angiography (CCTA) Coronary magnetic resonance imaging (CMR) Echocardiography<br>|
| Active Comparator: Control<br>TnI <0.06 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging | Other: Minimal invasive cardiac imaging<br>* Coronary CT angiography (CCTA) Coronary magnetic resonance imaging (CMR) Echocardiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery disease | Coronary artery disease with luminal narrowing > 50 % in one or more major epicardial vessels by CCTA. | During hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary calcium score | Agatston coronary calcium score | During hospital admission | 
| Extent of coronary artery atherosclerosis | Presence and extent of coronary artery atherosclerosis as measured with coronary CCTA | During hospital admission | 
| Minimal myocardial injury | Minimal myocardial injury measured by late gadolinium enhancement on CMR. | During hospital admission |