Identifying Vulnerable Plaques in Blood Vessels of the Heart Using a New Imaging Technique

October 20, 2025 updated by: Guillermo Tearney, Massachusetts General Hospital

Natural History of Vulnerable Coronary Plaques

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Atherosclerosis is a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries; these deposits are known as plaque. As plaque builds up, it increases the risk of heart attack. Previous autopsy studies have shown that vulnerable plaques, a type of atherosclerotic plaque, are commonly found in people who have had a heart attack. Until recently it has been difficult to identify vulnerable plaques in people prior to their death. Many people who have coronary artery disease and are at risk of having a heart attack undergo angioplasty, a procedure that opens a narrowed or blocked blood vessel. During angioplasty, imaging devices are often used to take pictures of the inside of blood vessels. The most commonly used imaging device, an intravenous ultrasound (IVUS) catheter, is threaded through the blood vessels and uses sound waves to take pictures. An OFDI is a new type of catheter that takes more detailed pictures of blood vessel walls and plaques. The additional detail provided by OFDI images may improve detection of vulnerable plaques, which may help physicians identify people who are at high risk of having a heart attack. This study will use standard IVUS imaging and OFDI to examine vulnerable plaques within blood vessels of the heart and to evaluate any changes that occur over time in heart blood vessels and plaque.

This study will enroll participant with coronary artery disease who are undergoing angioplasty. At a baseline study visit, participants will first undergo an angiography procedure, in which x-ray pictures will be taken of the heart blood vessels. Participants will then be randomly assigned to undergo either the IVUS procedure followed by the OFDI procedure or vice versa. Repeat angiographies will occur after each imaging procedure. Next, participants will undergo angioplasty and a stent will be placed at the area of the blood vessel that is narrowed or blocked to keep the blood vessel open. Finally, participants will undergo repeat IVUS and OFDI procedures. For some participants, the study physician may perform the IVUS and OFDI procedures only after the angioplasty. Every six months and for a period of two years, participants will complete questionnaires about medication history and heart problems that may have occurred since the baseline visit.Blood collection will occur if this is done during office visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • New York
      • New York, New York, United States, 10032
        • Columbia Presbyterian Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OFDI imaging
OFDI catheter advanced to the distal coronary artery
Device: OFDI imaging
Intervention of OFDI system and Imaging of the culprit lesion using the OFDI system.
Experimental: Intravenous Ultrasound
Randomization to determine whether Intravenous Ultrasound will be conducted before or after OFDI imaging.
Device: OFDI imaging
Intervention of OFDI system and Imaging of the culprit lesion using the OFDI system.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine prevalence of vulnerable plaques
Time Frame: 2 years
Number of subjects with vulnerable plaques
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillermo Tearney, MD, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2007

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2007

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2007

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2005-P000646
  • R01HL076398 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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