Non-invasive and Invasive Plaque Characterisation

Not Applicable

Terminated

• Conditions: Non ST Elevation Myocardial Infarction
• Interventions: Device: Imaging

• Registration Number: NCT01833338
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-16
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Imaging	There is only one arm in this study. All patients undergo MSCT, IVUS and OCT.

Primary Outcome Measures

Name	Time	Method
Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated.	24 hours	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

Name	Time	Method
Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated.	24 hours	A maximum interval of 24 hours between MSCT and IVUS/OCT is allowed in this study.

Trial Locations

Locations (1)

University Medical Center Groningen, Departments of Cardiology and Radiology; 🇳🇱 Groningen, Netherlands