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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01833338

Enrollment

Registered

2013-04-16

Start date

2011-06-30

Completion date

2013-05-31

Last updated

2014-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non ST Elevation Myocardial Infarction

Keywords

Non ST elevation myocardial infarction, optical coherence tomography, intravascular ultrasound, multi-slice computed tomography

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.

Interventions

DEVICEImaging

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026