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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Myocardium; Injury
• Intervention / Treatment: Other: Minimal invasive cardiac imaging

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands
    • Recruiting
    • UMC Utrecht
    • Contact: Hendrik M. Nathoe, MD PhD; Phone Number: + 31 88 755 7273; Email: h.m.nathoe@umcutrecht.nl
    • Principal Investigator: Hendrik M. Nathoe, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Hendrik M. Nathoe, MD PhD, UMC Utrecht

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Wounds and Injuries
• Other Study ID Numbers: AMI-NCS