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OCT-NIRAF Imaging for Coronary Artery Disease

N/A

Waitlist Available

Led By Guillermo J 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

Patient eligible for PCI

Patients must be over the age of 18

Must not have

Renal insufficiency (GRF<60 ml/min/1.73m2)

Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema

Timeline

Screening 3 weeks

Treatment Varies

Follow Up data will be analyzed within 1 year after the procedure.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use imaging techniques to study patients undergoing coronary angiography for heart conditions. They will be imaged with two different methods, OCT-NIRAF and CCTA, to see if the

Who is the study for?

This trial is for individuals undergoing coronary angiography due to stable or acute coronary disease and who are candidates for a procedure called PCI. Specific details about who can join or reasons why someone might not be eligible are not provided.

What is being tested?

The study is testing OCT-NIRAF imaging during heart procedures to see if the level of NIRAF signal in arteries correlates with how severe the artery disease is, and if it can predict worsening of the condition over time.

What are the potential side effects?

Potential side effects are not explicitly mentioned, but as with any imaging technique used during cardiac procedures, there may be risks associated with contrast use, radiation exposure from CCTA, and complications related to catheter insertion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for a brain radiation procedure.

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I am over 18 years old.

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I have stable or acute heart issues and am getting a heart artery exam at MGH.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced.

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I do not have severe heart issues like sudden chest pain, very low blood pressure, or serious heart failure.

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I have not had any emergency medical procedures recently.

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I do not have a serious illness expected to shorten my life to under a year.

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I cannot attend follow-up appointments.

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I am not part of any study using OCT imaging or trials for unapproved heart drugs/devices.

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I am not a candidate for certain heart imaging tests or procedures.

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My heart's main artery is more than half blocked.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ data will be analyzed within 1 year after the procedure.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~data will be analyzed within 1 year after the procedure.

This trial's timeline: 3 weeks for screening, Varies for treatment, and data will be analyzed within 1 year after the procedure. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Plaque progression estimate using OCT-NIRAF

Plaque size estimation using OCT-NIRAF

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with stable CAD or acute coronary syndromes undergoing invasive coronary angiographyExperimental Treatment1 Intervention

Patients referred to the Cardiology Division of the Massachusetts General Hospital, undergoing coronary angiography for stable or acute coronary disease and eligible for percutaneous coronary intervention (PCI) will be eligible for the study.

0 / 11Eligibility criteria met