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

UMC Utrecht

Status: Unknown

Conditions: Coronary Artery Disease; Myocardium; Injury

Treatments: Other: Minimal invasive cardiac imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01960309

AMI-NCS

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 6 patient groups

1. TnI elevation

Experimental group

Description:

TnI 0.06-0.60ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging

Treatment:

Other: Minimal invasive cardiac imaging

2. TnI elevation

Experimental group

Description:

TnI 0.61-6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging

Treatment:

Other: Minimal invasive cardiac imaging

3. TnI elevation

Experimental group

Description:

TnI\>6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging

Treatment:

Other: Minimal invasive cardiac imaging

4. TnI elevation

Experimental group

Description:

TnI \>6.00 ng/ml, ischemia on ECG and Hb\<5.1. Intervention: minimal invasive cardiac imaging

Treatment:

Other: Minimal invasive cardiac imaging

5. TnI elevation

Experimental group

Description:

TnI \>6.00 ng/ml, ischemia on ECG and Hb\>5.0. Intervention: minimal invasive cardiac imaging

Treatment:

Other: Minimal invasive cardiac imaging

Control

Active Comparator group

Description:

TnI \<0.06 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging

Treatment:

Other: Minimal invasive cardiac imaging