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Which heart test is best for women? new study aims to find out

NCT ID NCT04599192

Knowledge-focused Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study looks at 500 women with chest pain to compare two tests used during heart catheterization—FFR and iFR—to see which better predicts future heart problems like heart attacks or strokes. Participants will be followed for 5 years. The goal is to improve how doctors decide on treatment for women with heart disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult female patients (\>18 years of age) presenting with suspected myocardial ischemia or acute coronary syndrome for evaluation of ischemia by non-invasive stress testing and coronary angiography.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female ≥ 18 years old at signing of informed consent 2. Suspected myocardial ischemia or acute coronary syndrome 3. Indication for non-invasive perfusion imaging study 4. Indication for diagnostic catheterization 5. Eligible for PCI 6. Signed informed clinical procedural consent by subject or by surrogate Exclusion Criteria: 1. Inability to receive adenosine or regadenoson (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker. 2. Severe cardiomyopathy (ejection fraction \<30%) 3. Extremely tortuous or calcified coronary arteries precluding FFR/iFR measurements 4. Patients with left main coronary artery disease requiring revascularization 5. Female of child baring age should have negative pregnancy test 6. Subject is pregnant or breast feeding, or planning to become pregnant 7. Contraindication to non-invasive stress imaging including severe claustrophobia, renal disease with GFR \<30 where CMR is indication, any metal in the body which is a contraindication to CMR, allergy to gadolinium contrast 8. ICD or PPM

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Coronary Disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac catheterization Coronary disease Exercise test Myocardial perfusion imaging Percutaneous coronary intervention

Contacts and locations

Locations

  • Yale University School of Medicine - Section of Cardiology

    New Haven, Connecticut, 06520, United States

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