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

NCT01960309 | Unknown DMC

• 1 other identifier: AMI-NCS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardium; Injury; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Coronary artery disease

  Coronary artery disease with luminal narrowing \> 50 % in one or more major epicardial vessels by CCTA.

  During hospital admission

Secondary Outcomes (3)

• Coronary calcium score

  During hospital admission

• Extent of coronary artery atherosclerosis

  During hospital admission

• Minimal myocardial injury

  During hospital admission

Study Arms (6)

1. TnI elevation

EXPERIMENTAL

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

Other: Minimal invasive cardiac imaging

2. TnI elevation

EXPERIMENTAL

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

Other: Minimal invasive cardiac imaging

3. TnI elevation

EXPERIMENTAL

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

Other: Minimal invasive cardiac imaging

4. TnI elevation

EXPERIMENTAL

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

Other: Minimal invasive cardiac imaging

5. TnI elevation

EXPERIMENTAL

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

Other: Minimal invasive cardiac imaging

Control

ACTIVE COMPARATOR

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

Other: Minimal invasive cardiac imaging

Interventions

Minimal invasive cardiac imaging OTHER

* Coronary CT angiography (CCTA) * Coronary magnetic resonance imaging (CMR) * Echocardiography

1. TnI elevation; 2. TnI elevation; 3. TnI elevation; 4. TnI elevation; 5. TnI elevation; Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hendrik M. Nathoe, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hendrik M. Nathoe, MD PhD

CONTACT

+31 88 755 7273; H.M.Nathoe@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: W.A. van Klei, MD PhD

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: October 10, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

NL (1)