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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
Women with childbearing potential must have a negative pregnancy test within the 7 days prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am receiving treatment for blocked heart arteries.
Select...
I am a woman who can have children and I have a negative pregnancy test from the last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,515 Total Patients Enrolled
21 Trials studying Coronary Artery Disease
10,188 Patients Enrolled for Coronary Artery Disease
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,290,555 Total Patients Enrolled
165 Trials studying Coronary Artery Disease
268,712 Patients Enrolled for Coronary Artery Disease
Guillermo Tearney, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
835 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition affecting the main artery of my heart.I have had heart bypass surgery.I am receiving treatment for blocked heart arteries.I am a woman who can have children and I have a negative pregnancy test from the last week.My kidney function is reduced.I had a severe heart attack within the last 3 days and my heart markers are still high.I have active heart-related chest pain.I have severe issues with blood flow in my limbs.I recently had a type of heart attack without ST elevation and ongoing heart muscle stress.I have complex heart issues, including twisted blood vessels or clots.I have been diagnosed with congestive heart failure.I have had emergency medical procedures.I cannot come back for follow-up visits.
Research Study Groups:
This trial has the following groups:- Group 1: OFDI imaging
- Group 2: Intravenous Ultrasound
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies in this clinical experiment which individuals can take part in?
"According to the clinicaltrials.gov data, this particular trial is not actively searching for participants. It was initially posted in 2007 and last updated in 2021. However, there are currently 571 other trials recruiting patients as of now."
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