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

Not Applicable

• Conditions: Myocardium; Injury; Coronary Artery Disease
• Interventions: Other: Minimal invasive cardiac imaging

• Registration Number: NCT01960309
• Lead Sponsor: UMC Utrecht

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03
• Primary Completion: 2015-06
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. TnI elevation	Minimal invasive cardiac imaging	TnI 0.06-0.60ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
3. TnI elevation	Minimal invasive cardiac imaging	TnI\>6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
5. TnI elevation	Minimal invasive cardiac imaging	TnI \>6.00 ng/ml, ischemia on ECG and Hb\>5.0. Intervention: minimal invasive cardiac imaging
4. TnI elevation	Minimal invasive cardiac imaging	TnI \>6.00 ng/ml, ischemia on ECG and Hb\<5.1. Intervention: minimal invasive cardiac imaging
2. TnI elevation	Minimal invasive cardiac imaging	TnI 0.61-6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
Control	Minimal invasive cardiac imaging	TnI \<0.06 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging

Primary Outcome Measures

Name	Time	Method
Coronary artery disease	During hospital admission	Coronary artery disease with luminal narrowing \> 50 % in one or more major epicardial vessels by CCTA.

Secondary Outcome Measures

Name	Time	Method
Coronary calcium score	During hospital admission	Agatston coronary calcium score
Extent of coronary artery atherosclerosis	During hospital admission	Presence and extent of coronary artery atherosclerosis as measured with coronary CCTA
Minimal myocardial injury	During hospital admission	Minimal myocardial injury measured by late gadolinium enhancement on CMR.

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands