Non-invasive and Invasive Plaque Characterisation

NCT01833338 | Terminated

• 1 other identifier: METcUMCG 2010.266
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non ST Elevation Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated.

  24 hours

Study Arms (1)

Single arm

OTHER

There is only one arm in this study. All patients undergo MSCT, IVUS and OCT.

Device: Imaging

Interventions

Imaging DEVICE

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

Also known as: 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen, Departments of Cardiology and Radiology

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gabija Pundziute, MD, PhD

  Department of Cardiology

  PRINCIPAL INVESTIGATOR

• Tineke Willems, MD, PhD

  Department of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: April 16, 2013
• Study Start: June 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

NL (1)