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Clinical Trials/NCT01960309
NCT01960309
Unknown
Not Applicable

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

UMC Utrecht1 site in 1 country70 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardium; Injury
Sponsor
UMC Utrecht
Enrollment
70
Locations
1
Primary Endpoint
Coronary artery disease
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
August 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wilton A van Klei

W.A. van Klei, MD PhD

UMC Utrecht

Eligibility Criteria

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

Outcomes

Primary Outcomes

Coronary artery disease

Time Frame: During hospital admission

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

Secondary Outcomes

  • Coronary calcium score(During hospital admission)
  • Extent of coronary artery atherosclerosis(During hospital admission)
  • Minimal myocardial injury(During hospital admission)

Study Sites (1)

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