Non-invasive and Invasive Plaque Characterisation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non ST Elevation Myocardial Infarction

Intervention / Treatment
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* Device: Imaging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>There is only one arm in this study. All patients undergo MSCT, IVUS and OCT. | Device: Imaging<br>* All patients undergo non-invasive (MSCT) and invasive (IVUS, OCT) imaging<br>* Other names: MSCT: Dual-source CT scanner Somatom Definition, Siemens Healhtcare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non ST elevation myocardial infarction, optical coherence tomography, intravascular ultrasound, multi-slice computed tomography