Non-invasive and Invasive Plaque Characterisation

Non ST Elevation Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01833338
• Other study ID #: METcUMCG 2010.266
• Status: Terminated
• Phase: N/A
• First received: March 4, 2013
• Last updated: September 10, 2014
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: September 2014
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non ST Elevation Myocardial Infarction

Intervention

Device:
• Imaging
All patients undergo non-invasive (MSCT) and invasive (IVUS, OCT) imaging

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen, Departments of Cardiology and Radiology	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated.	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).	24 hours	No
Secondary	Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated.	A maximum interval of 24 hours between MSCT and IVUS/OCT is allowed in this study.	24 hours	No