Non-invasive and Invasive Plaque Characterisation

Sponsor

University Medical Center Groningen (Other)

Overall Status

Terminated

CT.gov ID

NCT01833338

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non ST Elevation Myocardial Infarction	Device: Imaging	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Jun 1, 2011

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: Single arm There is only one arm in this study. All patients undergo MSCT, IVUS and OCT.	Device: Imaging All patients undergo non-invasive (MSCT) and invasive (IVUS, OCT) imaging Other Names: 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

Arm

Intervention/Treatment

Other: Single arm

There is only one arm in this study. All patients undergo MSCT, IVUS and OCT.

Device: Imaging

All patients undergo non-invasive (MSCT) and invasive (IVUS, OCT) imaging

Other Names:

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.