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Diagnostic Study for Heart Disease

N/A

Recruiting

Led By Nathaniel Smilowitz, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Stable ischemic heart disease, defined by ischemic symptoms and/or myocardial ischemia by stress testing

Be older than 18 years old

Must not have

Prior percutaneous coronary intervention or coronary artery bypass grafting

Active bleeding and/or bleeding diathesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at women with stable heart disease who don't have blockages in their coronary arteries. A substantial proportion of these patients have ischemia (reduced blood flow) based on symptoms or stress testing. This may be due to microvascular dysfunction, which is an abnormal function of the tiny arteries in the heart. The mechanisms and optimal treatment of coronary microvascular dysfunction are unknown. This trial will evaluate the association between platelet activity, inflammation, and microvascular dysfunction.

Who is the study for?

This study is for adult women over 18 with stable ischemic heart disease, who are taking aspirin and referred for coronary angiography. It's not suitable for those with severe heart failure, recent heart attacks, certain blood disorders or bleeding risks, pregnancy, or known allergies to adenosine.

What is being tested?

The trial investigates the link between platelet activity, inflammation and coronary microvascular dysfunction using a Pressure-Temperature Sensor Guidewire during angiography. Medications like Bivalirudin, Adenosine and Heparin will be used alongside standard procedures.

What are the potential side effects?

Possible side effects include bleeding due to anticoagulants (Bivalirudin and Heparin), chest pain or shortness of breath from Adenosine infusion reactions. The sensor guidewire procedure carries risks similar to any catheterization such as bruising or infection at the insertion site.

Eligibility Criteria

Inclusion Criteria

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

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My heart condition is stable, with symptoms or test results showing reduced blood flow to my heart.

Exclusion Criteria

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

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

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I am currently experiencing active bleeding or have a bleeding disorder.

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I have a serious heart valve condition.

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I cannot receive adenosine IV due to allergies, severe asthma, heart rhythm problems, or a pacemaker.

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I have a thickened heart muscle that obstructs blood flow.

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I have severe heart failure.

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I have had a heart attack in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Non-Obstructive CADExperimental Treatment5 Interventions

After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bivalirudin

2003

Completed Phase 4

~21860

Heparin

2003

Completed Phase 4

~22600