Non-invasive and Invasive Plaque Characterisation
This study has been terminated.
(The study was terminated based on an included stopping rule in the study protocol)
Information provided by (Responsible Party):
Gabija Pundziute, University Medical Centre Groningen
First received: March 4, 2013
Last updated: September 10, 2014
Last verified: September 2014
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.
Non ST Elevation Myocardial Infarction
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||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
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
There is only one arm in this study. All patients undergo MSCT, IVUS and OCT.
All patients undergo non-invasive (MSCT) and invasive (IVUS, OCT) imaging
- 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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01833338
|University Medical Center Groningen, Departments of Cardiology and Radiology
|Groningen, Netherlands, 9700 RB |
University Medical Centre Groningen
||Gabija Pundziute, MD, PhD
||Department of Cardiology
||Tineke Willems, MD, PhD
||Department of Radiology
No publications provided
||Gabija Pundziute, Principal Investigator, University Medical Centre Groningen
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 4, 2013
||September 10, 2014
||Netherlands: Medical Ethics Review Committee (METC)
Keywords provided by University Medical Centre Groningen:
Non ST elevation myocardial infarction
optical coherence tomography
multi-slice computed tomography
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014
Acute Coronary Syndrome
Signs and Symptoms