Non-invasive and Invasive Plaque Characterisation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
Gabija Pundziute, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01833338
First received: March 4, 2013
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Non ST Elevation Myocardial Infarction
Device: Imaging

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

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    A maximum interval of 24 hours between MSCT and IVUS/OCT is allowed in this study.


Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm
There is only one arm in this study. All patients undergo MSCT, IVUS and OCT.
Device: Imaging
All patients undergo non-invasive (MSCT) and invasive (IVUS, OCT) imaging
Other Names:
  • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833338

Contacts
Contact: Wouter G Wieringa, MD +31 50 3613485 w.g.wieringa@umcg.nl
Contact: Chris PH Lexis, MD

Locations
Netherlands
University Medical Center Groningen, Departments of Cardiology and Radiology Recruiting
Groningen, Netherlands, 9700 RB
Contact: Gabija Pundziute, MD, PhD    +31 50 3619477    g.pundziute@umcg.nl   
Principal Investigator: Gabija Pundziute, MD, PhD         
Principal Investigator: Tineke Willems, MD,PhD         
Sub-Investigator: Wouter G Wieringa, MD         
Sub-Investigator: Chris PH Lexis, MD         
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Gabija Pundziute, MD, PhD Department of Cardiology
Principal Investigator: Tineke Willems, MD, PhD Department of Radiology
  More Information

No publications provided

Responsible Party: Gabija Pundziute, Principal Investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01833338     History of Changes
Other Study ID Numbers: METcUMCG 2010.266
Study First Received: March 4, 2013
Last Updated: April 12, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Non ST elevation myocardial infarction
optical coherence tomography
intravascular ultrasound
multi-slice computed tomography

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 09, 2014