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Imaging Techniques for Angina

N/A

Waitlist Available

Led By Krishna Patel, MBBS, MSc

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with symptoms of exertional angina and/or dyspnea (confirmed on Seattle Angina Questionnaire and Rose Dyspnea Questionnaire)

Evidence of non-obstructive CAD on CCTA or coronary angiography (no stenosis >50% and/or FFR if performed >0.80)

Must not have

Contraindications to regadenoson (severe asthma/chronic obstructive pulmonary disease, brady-arrhythmias, or systolic blood pressure <90 mm Hg)

Patients with eGFR <30 ml/min/m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks to develop a non-invasive algorithm to diagnose & manage patients with suspected angina & ischemia but no obstructive coronary artery disease (CAD). It will assess the improvement in patient symptoms, function & quality of life from PET-guided management.

Who is the study for?

This trial is for patients with symptoms of exertional angina or shortness of breath, who have non-obstructive coronary artery disease confirmed by tests. It's not for those with severe kidney issues, certain heart conditions, pregnant women, or people unable to consent.

What is being tested?

The study aims to develop a non-invasive method using PET scans and other imaging techniques to diagnose and manage microvascular dysfunction in patients without significant coronary artery blockages.

What are the potential side effects?

Potential side effects may include reactions related to the PET imaging agent (like nausea), discomfort from exercise during the stress test, and risks associated with CT angiograms such as radiation exposure.

Eligibility Criteria

Inclusion Criteria

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

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I experience chest pain or shortness of breath when I exert myself.

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My heart's arteries are not severely blocked.

Exclusion Criteria

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

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I do not have severe asthma/COPD, heart rhythm problems, or very low blood pressure.

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My kidney function is low, with an eGFR under 30.

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I have had a procedure to improve blood flow to my heart.

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My heart's pumping ability is below normal, or I have cardiomyopathy.

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I have moderate or severe heart valve disease.

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I need a heart scan for reasons other than heart artery disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Euro-QOL 5 Dimension Visual Analog Scale (EQ5D-VAS)

Number of ER admissions for chest pain per participant

Number of use of other invasive or non-invasive diagnostic procedures for CAD

+2 more

Secondary study objectives

Number of participants with METs >=10 METS

The Bruce protocol score

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 INOCAExperimental Treatment4 Interventions

Patients to undergo coronary angiogram and/or coronary CT angiogram for suspected ischemic symptoms of angina and dyspnea but do not have obstructive epicardial coronary artery disease.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET imaging

2005

Completed Phase 3

~670

0 / 8Eligibility criteria met