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

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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 : June 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

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U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01833338

University Medical Center Groningen, Departments of Cardiology and Radiology
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Principal Investigator: Gabija Pundziute, MD, PhD Department of Cardiology
Principal Investigator: Tineke Willems, MD, PhD Department of Radiology

Responsible Party: Gabija Pundziute, Principal Investigator, University Medical Center Groningen Identifier: NCT01833338     History of Changes
Other Study ID Numbers: METcUMCG 2010.266
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014

Keywords provided by Gabija Pundziute, University Medical Center Groningen:
Non ST elevation myocardial infarction
optical coherence tomography
intravascular ultrasound
multi-slice computed tomography

Additional relevant MeSH terms:
Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases