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Imaging Technique

OFDI Imaging for Coronary Artery Disease

N/A
Waitlist Available
Led By Guillermo Tearney, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing PCTI for coronary artery disease
Be older than 18 years old
Must not have
Unprotected left main coronary artery disease
Prior coronary artery bypass surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will use a new imaging technique to study the presence of a specific type of plaque in people with coronary artery disease.

Who is the study for?
This trial is for people with coronary artery disease who are undergoing a procedure called PCTI. Women of childbearing age must test negative for pregnancy before joining. People can't join if they have kidney issues, recent heart attacks, complex heart lesions, severe vascular disease, congestive heart failure, previous bypass surgery or are in another study.
What is being tested?
The trial is testing a new imaging method called OFDI to spot vulnerable plaques in the arteries that could lead to heart attacks. It aims to see how well this technique works in identifying these risky plaques compared to current methods.
What are the potential side effects?
Since OFDI is an imaging technique and not a drug or invasive treatment, side effects may be minimal but could include discomfort during the imaging process or potential risks associated with additional exposure during PCTI.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am receiving treatment for blocked heart arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition affecting the main artery of my heart.
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I have had heart bypass surgery.
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My kidney function is reduced.
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I had a severe heart attack within the last 3 days and my heart markers are still high.
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I have active heart-related chest pain.
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I have severe issues with blood flow in my limbs.
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I recently had a type of heart attack without ST elevation and ongoing heart muscle stress.
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I have complex heart issues, including twisted blood vessels or clots.
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I have been diagnosed with congestive heart failure.
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I have had emergency medical procedures.
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I cannot come back for follow-up visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine prevalence of vulnerable plaques

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: OFDI imagingExperimental Treatment1 Intervention
OFDI catheter advanced to the distal coronary artery
Group II: Intravenous UltrasoundExperimental Treatment1 Intervention
Randomization to determine whether Intravenous Ultrasound will be conducted before or after OFDI imaging.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,317,625 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,791,978 Total Patients Enrolled
Guillermo Tearney, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
835 Total Patients Enrolled

Media Library

OFDI imaging (Imaging Technique) Clinical Trial Eligibility Overview. Trial Name: NCT00540761 — N/A
Heart disease Research Study Groups: OFDI imaging, Intravenous Ultrasound
Heart disease Clinical Trial 2023: OFDI imaging Highlights & Side Effects. Trial Name: NCT00540761 — N/A
OFDI imaging (Imaging Technique) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00540761 — N/A
~32 spots leftby Dec 2026
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