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Ranolazine for Heart Disease

N/A

Recruiting

Led By C.Noel Bairey-Merz, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

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

Must have

Age > 18 years old

Women and men with signs and symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing) or microvascular angina (MVA) which is defined as angina and ischemic ECG changes without organic obstructive stenosis or epicardial spasm of the coronary arteries

Must not have

LV dysfunction (ejection fraction <40%)

Documented obstructive myocardiopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether or not a new drug, ranolazine, can improve the symptoms of Cardiac Syndrome X in women.

Who is the study for?

This trial is for adults over 18 who experience chest pain or signs of heart strain but don't have major blockages in their large heart arteries. It's open to both women and men with specific types of angina or related symptoms, provided they've had no severe coronary artery disease diagnosed in the last two years.

What is being tested?

The study tests noninvasive methods to diagnose small vessel heart disease, which may cause chest pain without showing up on standard checks. The goal is to improve diagnosis and treatment, potentially reducing health risks and costs associated with misdiagnosis.

What are the potential side effects?

Since this trial involves noninvasive testing rather than medication or surgical interventions, side effects are minimal. However, some individuals might experience discomfort or anxiety during testing procedures.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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I experience chest pain or discomfort due to heart issues without major artery blockages.

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I understand the information given to me and can make decisions about my health care.

Exclusion Criteria

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

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My heart's pumping ability is reduced.

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I have been diagnosed with a heart condition that blocks blood flow.

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I have been diagnosed with a type of heart attack or chest pain.

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I have had or am planning to have heart surgery or had a heart attack in the last 30 days.

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I have a serious illness, not heart-related, with a life expectancy of less than 4 years.

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I have a significant blockage in at least one of my heart's major arteries.

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I have severe heart failure and am receiving treatment.

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I need heart valve surgery.

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My chest pain is not caused by heart artery blockages.

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I cannot take adenosine or Lexiscan due to health reasons.

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I am unable to understand and agree to the study's details on my own.

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I am currently experiencing severe heart failure requiring advanced support.

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: Single ArmExperimental Treatment1 Intervention

1. fill out baseline demographic and health/medical history questionnaires, CV risk factors, reasons of diagnosis of ischemia, information of coronary artery, and medication use 2. undergo clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory (Appendix); 3. undergo noninvasive Peripheral Artery Tonometry (PAT) testing (Appendix); 4. undergo clinically indicated Cardiac Magnetic Resonance (CMR) imaging (Appendix) to detect subendocardial ischemia (if indicated and referred by the treating physician). The three tests (heart catheterization with adenosine coronary flow reserve testing, acetylcholine provocative vasomotor testing during heart catheterization, cardiac MRI) are performed for standard care. 5. have blood and urine testing. 6. fill out health questionnaires 7. be followed prospectively 6-week, 6-month, and annually for clinical status

0 / 15Eligibility criteria met