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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR)

Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)

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

Adenosine

2009

Completed Phase 3

~3670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,561 Total Patients Enrolled

Nathaniel Smilowitz, MDPrincipal InvestigatorNYU Langone Health

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Diagnostic Coronary Angiography with Non-Obstructive CAD Clinical Trial Eligibility Overview. Trial Name: NCT03537586 — N/A

Coronary Microvascular Disease Research Study Groups: Non-Obstructive CAD

Coronary Microvascular Disease Clinical Trial 2023: Diagnostic Coronary Angiography with Non-Obstructive CAD Highlights & Side Effects. Trial Name: NCT03537586 — N/A

Diagnostic Coronary Angiography with Non-Obstructive CAD 2023 Treatment Timeline for Medical Study. Trial Name: NCT03537586 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently available slots for participants in this experiment?

"Affirmative. Per clinicaltrials.gov, this medical trial is now accepting applicants. This study was first posted on June 29th 2018 and has recently been updated as of April 29th 2022. At present, the team behind it needs to enroll roughly 100 people from a single site."

Answered by AI

Is the age limit for this experiment restricted to adults only?

"This medical trial is seeking participants aged between 18 and 125 years old. Separately, there are 125 trials that cater to patients younger than 18 while 997 studies comprise those older than 65."

Answered by AI

What is the current capacity for participants in this experiment?

"Confirmed. According to the records on clinicaltrials.gov, this medical study which was first published in June 2018 is still open for recruitment and requires 100 participants from a single site as of April 2022."

Answered by AI