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

Coronary Artery Disease Clinical Trial

— AMI-NCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01960309
• Other study ID #: AMI-NCS
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2013
• Last updated: December 2, 2014
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: December 2014
• Source: UMC Utrecht
• Contact: Hendrik M. Nathoe, MD PhD
• Phone: +31 88 755 7273
• Email: H.M.Nathoe[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Myocardium; Injury

Intervention

Other:
• Minimal invasive cardiac imaging
Coronary CT angiography (CCTA) Coronary magnetic resonance imaging (CMR) Echocardiography

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary artery disease	Coronary artery disease with luminal narrowing > 50 % in one or more major epicardial vessels by CCTA.	During hospital admission	No
Secondary	Coronary calcium score	Agatston coronary calcium score	During hospital admission	No
Secondary	Extent of coronary artery atherosclerosis	Presence and extent of coronary artery atherosclerosis as measured with coronary CCTA	During hospital admission	No
Secondary	Minimal myocardial injury	Minimal myocardial injury measured by late gadolinium enhancement on CMR.	During hospital admission	No