Non-invasive and Invasive Plaque Characterisation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01833338
Recruitment Status : Terminated (The study was terminated based on an included stopping rule in the study protocol)
First Posted : April 16, 2013
Last Update Posted : September 11, 2014
Information provided by (Responsible Party):
Gabija Pundziute, University Medical Center Groningen

March 4, 2013
April 16, 2013
September 11, 2014
June 2011
May 2013   (Final data collection date for primary outcome measure)
Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated. [ Time Frame: 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).
Same as current
Complete list of historical versions of study NCT01833338 on Archive Site
Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated. [ Time Frame: 24 hours ]
A maximum interval of 24 hours between MSCT and IVUS/OCT is allowed in this study.
Same as current
Not Provided
Not Provided
Non-invasive and Invasive Plaque Characterisation
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
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.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Non ST Elevation Myocardial Infarction
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
Single arm
There is only one arm in this study. All patients undergo MSCT, IVUS and OCT.
Intervention: Device: Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
METcUMCG 2010.266
Not Provided
Not Provided
Gabija Pundziute, University Medical Center Groningen
University Medical Center Groningen
Not Provided
Principal Investigator: Gabija Pundziute, MD, PhD Department of Cardiology
Principal Investigator: Tineke Willems, MD, PhD Department of Radiology
University Medical Center Groningen
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP