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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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.

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,993 Previous Clinical Trials

13,230,401 Total Patients Enrolled

22 Trials studying Coronary Artery Disease

10,229 Patients Enrolled for Coronary Artery Disease

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,889 Previous Clinical Trials

47,833,887 Total Patients Enrolled

166 Trials studying Coronary Artery Disease

268,902 Patients Enrolled for Coronary Artery Disease

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

Coronary Artery Disease Research Study Groups: OFDI imaging, Intravenous Ultrasound

Coronary Artery 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

~18 spots leftby Sep 2025

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