Non-invasive and Invasive Plaque Characterisation

NCT ID: NCT01833338

Last Updated: 2014-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non ST Elevation Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm

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

Group Type OTHER

Imaging

Intervention Type DEVICE

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

Interventions

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Imaging

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

Intervention Type DEVICE

Other Intervention Names

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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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Gabija Pundziute

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabija Pundziute, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology

Tineke Willems, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology

Locations

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University Medical Center Groningen, Departments of Cardiology and Radiology

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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METcUMCG 2010.266

Identifier Type: -

Identifier Source: org_study_id

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