Back to resultsNon-invasive and Invasive Plaque Characterisation
Primary Purpose
Non ST Elevation Myocardial Infarction
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Non ST Elevation Myocardial Infarction focused on measuring Non ST elevation myocardial infarction, optical coherence tomography, intravascular ultrasound, multi-slice computed tomography
Eligibility Criteria
Inclusion Criteria:
- Chest pain suggestive for myocardial ischemia for at least 30 minutes; - Electrocardiogram (ECG) with ST-segment shifts (ST-segment depression >1 mm in at least two contiguous leads or transient ST-segment elevation > 1mm with duration of < 30 min in at least two contiguous leads) and/or T-wave changes (T-wave inversion > 1.5 mm in at least three contiguous leads); - Positive hs Troponin T > 14 ng/L or positive Troponin T <0.01 µg/L - Clinical indication for invasive coronary angiography followed by PCI of the ischemia-related target lesion; - Informed consent.
Exclusion Criteria:
- Persistent ST-elevation of >1 mm in 2 or more leads; - Need for emergency invasive coronary angiography and percutaneous coronary intervention (PCI); - Need for emergency coronary artery bypass grafting; - Presence of cardiogenic shock; - Estimated glomerular filtration rate (eGFR) < 50 ml/min; - Known allergy to iodine contrast agents; - Cardiac rhythms other than sinus rhythm; - Inability to lay supine; - Inability tot sustain a breath-hold for 15 seconds; - Inability to provide informed consent.
Sites / Locations
- University Medical Center Groningen, Departments of Cardiology and Radiology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm
Arm Description
There is only one arm in this study. All patients undergo MSCT, IVUS and OCT.
Outcomes
Primary Outcome Measures
Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated.
All imaging methods will be performed in each patient. A 24 hour period is the maximum allowed time gap between MSCT and invasive imaging (OCT/IVUS).
Secondary Outcome Measures
Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated.
A maximum interval of 24 hours between MSCT and IVUS/OCT is allowed in this study.
Full Information
NCT ID
NCT01833338
First Posted
March 4, 2013
Last Updated
September 10, 2014
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT01833338
Brief Title
Non-invasive and Invasive Plaque Characterisation
Official Title
Coronary Artery Plaque Characterisation With Non-invasive Multi-Slice Computed Tomography and Invasive Intravascular Ultrasound and Optical Coherence Tomography in Patients With Acute Coronary Syndromes Without ST-segment Elevation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated based on an included stopping rule in the study protocol
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The accuracy of coronary plaque characterization with Multi-slice computed tomography as compared to intravascular ultrasound and optical coherence tomography will be investigated in patients presenting with acute coronary syndrome without ST-elevation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non ST Elevation Myocardial Infarction
Keywords
Non ST elevation myocardial infarction, optical coherence tomography, intravascular ultrasound, multi-slice computed tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Other
Arm Description
There is only one arm in this study. All patients undergo MSCT, IVUS and OCT.
Intervention Type
Device
Intervention Name(s)
Imaging
Other Intervention Name(s)
OCT: C7-XR™ OCT Intravascular Imaging System, St.Jude Medical, IVUS: Galaxy 2 IVUS Imaging System, Boston Scientific, MSCT: Dual-source CT scanner Somatom Definition, Siemens Healhtcare
Intervention Description
All patients undergo non-invasive (MSCT) and invasive (IVUS, OCT) imaging
Primary Outcome Measure Information:
Title
Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated.
Description
All imaging methods will be performed in each patient. A 24 hour period is the maximum allowed time gap between MSCT and invasive imaging (OCT/IVUS).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated.
Description
A maximum interval of 24 hours between MSCT and IVUS/OCT is allowed in this study.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chest pain suggestive for myocardial ischemia for at least 30 minutes; - Electrocardiogram (ECG) with ST-segment shifts (ST-segment depression >1 mm in at least two contiguous leads or transient ST-segment elevation > 1mm with duration of < 30 min in at least two contiguous leads) and/or T-wave changes (T-wave inversion > 1.5 mm in at least three contiguous leads); - Positive hs Troponin T > 14 ng/L or positive Troponin T <0.01 µg/L - Clinical indication for invasive coronary angiography followed by PCI of the ischemia-related target lesion; - Informed consent.
Exclusion Criteria:
Persistent ST-elevation of >1 mm in 2 or more leads; - Need for emergency invasive coronary angiography and percutaneous coronary intervention (PCI); - Need for emergency coronary artery bypass grafting; - Presence of cardiogenic shock; - Estimated glomerular filtration rate (eGFR) < 50 ml/min; - Known allergy to iodine contrast agents; - Cardiac rhythms other than sinus rhythm; - Inability to lay supine; - Inability tot sustain a breath-hold for 15 seconds; - Inability to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabija Pundziute, MD, PhD
Organizational Affiliation
Department of Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tineke Willems, MD, PhD
Organizational Affiliation
Department of Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen, Departments of Cardiology and Radiology
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
12. IPD Sharing Statement
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Non-invasive and Invasive Plaque Characterisation
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