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

NCT ID: NCT01960309

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardium; Injury Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1. TnI elevation

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

Group Type EXPERIMENTAL

Minimal invasive cardiac imaging

Intervention Type OTHER

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

2. TnI elevation

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

Group Type EXPERIMENTAL

Minimal invasive cardiac imaging

Intervention Type OTHER

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

3. TnI elevation

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

Group Type EXPERIMENTAL

Minimal invasive cardiac imaging

Intervention Type OTHER

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

4. TnI elevation

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

Group Type EXPERIMENTAL

Minimal invasive cardiac imaging

Intervention Type OTHER

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

5. TnI elevation

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

Group Type EXPERIMENTAL

Minimal invasive cardiac imaging

Intervention Type OTHER

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

Control

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

Group Type ACTIVE_COMPARATOR

Minimal invasive cardiac imaging

Intervention Type OTHER

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

Interventions

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Minimal invasive cardiac imaging

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Wilton A van Klei

W.A. van Klei, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hendrik M. Nathoe, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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UMC Utrecht

Utrecht, Utrecht, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Hendrik M. Nathoe, MD PhD

Role: CONTACT

[email protected]
+31 88 755 7273

Facility Contacts

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Hendrik M. Nathoe, MD PhD

Role: primary

[email protected]
+ 31 88 755 7273

Other Identifiers

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AMI-NCS

Identifier Type: -

Identifier Source: org_study_id