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

Primary Purpose

Myocardium; Injury, Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Minimal invasive cardiac imaging
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardium; Injury

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMC UtrechtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1. TnI elevation

2. TnI elevation

3. TnI elevation

4. TnI elevation

5. TnI elevation

Control

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Coronary calcium score
Agatston coronary calcium score
Extent of coronary artery atherosclerosis
Presence and extent of coronary artery atherosclerosis as measured with coronary CCTA
Minimal myocardial injury
Minimal myocardial injury measured by late gadolinium enhancement on CMR.

Full Information

First Posted
July 30, 2013
Last Updated
December 2, 2014
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT01960309
Brief Title
Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.
Acronym
AMI-NCS
Official Title
Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardium; Injury, Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. TnI elevation
Arm Type
Experimental
Arm Description
TnI 0.06-0.60ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
Arm Title
2. TnI elevation
Arm Type
Experimental
Arm Description
TnI 0.61-6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
Arm Title
3. TnI elevation
Arm Type
Experimental
Arm Description
TnI>6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
Arm Title
4. TnI elevation
Arm Type
Experimental
Arm Description
TnI >6.00 ng/ml, ischemia on ECG and Hb<5.1. Intervention: minimal invasive cardiac imaging
Arm Title
5. TnI elevation
Arm Type
Experimental
Arm Description
TnI >6.00 ng/ml, ischemia on ECG and Hb>5.0. Intervention: minimal invasive cardiac imaging
Arm Title
Control
Arm Type
Active Comparator
Arm Description
TnI <0.06 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
Intervention Type
Other
Intervention Name(s)
Minimal invasive cardiac imaging
Intervention Description
Coronary CT angiography (CCTA) Coronary magnetic resonance imaging (CMR) Echocardiography
Primary Outcome Measure Information:
Title
Coronary artery disease
Description
Coronary artery disease with luminal narrowing > 50 % in one or more major epicardial vessels by CCTA.
Time Frame
During hospital admission
Secondary Outcome Measure Information:
Title
Coronary calcium score
Description
Agatston coronary calcium score
Time Frame
During hospital admission
Title
Extent of coronary artery atherosclerosis
Description
Presence and extent of coronary artery atherosclerosis as measured with coronary CCTA
Time Frame
During hospital admission
Title
Minimal myocardial injury
Description
Minimal myocardial injury measured by late gadolinium enhancement on CMR.
Time Frame
During hospital admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hendrik M. Nathoe, MD PhD
Phone
+31 88 755 7273
Email
H.M.Nathoe@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik M. Nathoe, MD PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hendrik M. Nathoe, MD PhD
Phone
+ 31 88 755 7273
Email
h.m.nathoe@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Hendrik M. Nathoe, MD PhD

12. IPD Sharing Statement

Learn more about this trial

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

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