Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00622167

Purpose

The purpose of this study is to compare different methods of looking at atherosclerotic plaques in heart arteries. Identifying the characteristics of these plaques noninvasively would be very valuable. This study is looking at a new CT scanner (DSCT) to noninvasively image these plaques compared to invasive ultrasound (the current standard).

Condition	Intervention
Coronary Artery Disease	Device: Integrated Backscatter IVUS and dual source CT

MedlinePlus related topics: Coronary Artery Disease Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Comparison of Dual Source Computed Tomography (DSCT) With Integrated Backscatter Intravascular Ultrasound (IB-IVUS) and Contrast Angiography in the Assessment of Coronary Artery Disease

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Comparison of plaque characteristics between DSCT and IVUS. [ Time Frame: At time of imaging ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Integrated backscatter IVUS plaque characteristics and their relation to biomarker elevation post PCI. [ Time Frame: At time of imaging ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 All patients will receive integrated backscatter IVUS and dual source CT.	Device: Integrated Backscatter IVUS and dual source CT Integrated Backscatter IVUS and Dual Source CT

Detailed Description:

The primary objectives of this study are:

To compare with contrast angiography, the ability of DSCT to detect and quantify coronary artery stenoses.
To compare with gray-scale IVUS, the ability of DSCT to quantify plaque cross-sectional diameter & area measurements & plaque volume.
To evaluate the ability of DSCT to assess plaque morphology and quantify plaque components as compared to gray-scale and IB-IVUS.
To evaluate the ability of DSCT to identify & measure lesion remodeling compared to gray-scale IVUS.
To determine if pre-PCI evaluation of coronary plaque morphology by IB-IVUS can a) predict procedural success as assessed by adequate stent strut apposition and expansion and b) peri-procedural myocardial necrosis as measured by biomarker elevation.

Eligibility

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

Criteria

Inclusion Criteria:

Males or non-pregnant females
> / = 18 years of age
Scheduled for coronary angiography

Exclusion Criteria:

Acute ST-elevation myocardial infarction within last 72 hours
Current congestive heart failure
Current cardiogenic shock
Unstable clinical condition
Known cardiomyopathy (EF < 30%)
Creatinine >1.5 mg/dL
Definite allergy to iodinated contrast media
Current participation in an investigational drug or device research study
HR > 65 and contraindications to the administration of beta blockers

Exclusion criteria assessed during catheterization procedure

PCI of native coronary vessel not performed
Left main stenosis > 50%
Any vessel contraindicated for IVUS imaging
Any lesion contraindicated for IVUS imaging
Inability to pass IVUS catheter
PCI of bifurcation lesion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622167

Contacts

Contact: Iris McNulty, RN

(617) 726-2612

imcnulty@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Ik-Kyung Jang, MD, PhD

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Ik-Kyung Jang, MD, PhD )
Study ID Numbers:	2007P001842
Study First Received:	February 12, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00622167
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Plaque characteristics
DSCT
IVUS

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009