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

NCT00622167 | Terminated Results

• 1 other identifier: 2007P001842
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Artery Disease

Keywords

Plaque characteristics; DSCT; IVUS

Outcome Measures

Primary Outcomes (1)

• Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).

  Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).

  At time of imaging

Study Arms (1)

1

OTHER

All patients will receive integrated backscatter IVUS and dual source CT.

Device: Integrated Backscatter IVUS; Device: Dual Source Computed Tomography

Interventions

Integrated Backscatter IVUS DEVICE

All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.

1

Dual Source Computed Tomography DEVICE

All subjects have DSCT and IBIVUS imaging

1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

Study terminated after imaging 4 subjects due to slow enrollment. Results will not be analyzed.

Results Point of Contact

• Title: Iris McNulty, RN
• Organization: Massachusetts General Hospital

imcnulty@partners.org

617 726 2612

Study Officials

• Ik-Kyung Jang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Professor of Medicine

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2009
• Last Updated: February 3, 2012
• Results First Posted: February 3, 2012

Record last verified: 2012-01

Locations

US (1)