NCT00540761

Brief Summary

Atherosclerosis, a condition in which fatty deposits of plaque build up along the inner walls of arteries, is a condition that may increase the risk of having a heart attack. Previous studies have shown that the presence of a specific kind of plaque, known as vulnerable plaque, is often found in people who have had a heart attack. This study will use a new imaging technique called optical frequency domain imaging (OFDI) to examine the presence of vulnerable plaques in people with coronary artery disease.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jul 2007Dec 2028

Study Start

First participant enrolled

July 25, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
19.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

19.4 years

First QC Date

September 24, 2007

Last Update Submit

October 20, 2025

Conditions

Coronary Arteriosclerosis

Keywords

Coronary Artery DiseaseAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Determine prevalence of vulnerable plaques

    Number of subjects with vulnerable plaques

    2 years

Study Arms (2)

OFDI imaging

EXPERIMENTAL

OFDI catheter advanced to the distal coronary artery

Device: OFDI imaging

Intravenous Ultrasound

EXPERIMENTAL

Randomization to determine whether Intravenous Ultrasound will be conducted before or after OFDI imaging.

Device: OFDI imaging

Interventions

OFDI imagingDEVICE

Intervention of OFDI system and Imaging of the culprit lesion using the OFDI system.

Intravenous UltrasoundOFDI imaging

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing PCTI for coronary artery disease
  • Women with childbearing potential must have a negative pregnancy test within the 7 days prior to study entry

You may not qualify if:

  • Kidney insufficiency (i.e., GFR\<50ml/min)
  • OR pregnancy
  • OR participants who have had a ST elevation heart attack will be excluded for at least 72 hours post-heart attack and until cardiac enzymes return to normal. Participants who have had a non-ST elevation heart attack will be excluded if they have evidence of ongoing ischemia, defined as chest pain or new electrocardiogram (ECG) changes in the 12 hours prior to study entry and/or rising creatine kinase (CK) and CK-MB serum enzymes.
  • OR high-risk and complex lesions, including tortuous blood vessels and lesions with thrombosis
  • OR unprotected left main coronary artery disease
  • OR enrolled in another investigational clinical trial within the 6 months prior to study entry
  • OR severe peripheral vascular disease
  • OR active ischemia
  • OR congestive heart failure
  • OR prior coronary artery bypass surgery
  • OR emergent procedures
  • OR inability to return for study follow-up procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Waxman S, Freilich MI, Suter MJ, Shishkov M, Bilazarian S, Virmani R, Bouma BE, Tearney GJ. A case of lipid core plaque progression and rupture at the edge of a coronary stent: elucidating the mechanisms of drug-eluting stent failure. Circ Cardiovasc Interv. 2010 Apr;3(2):193-6. doi: 10.1161/CIRCINTERVENTIONS.109.917955. No abstract available.

    PMID: 20407116DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Guillermo Tearney, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pathology

Study Record Dates

First Submitted

September 24, 2007

First Posted

October 8, 2007

Study Start

July 25, 2007

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)