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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 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

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
512 Previous Clinical Trials
162,730 Total Patients Enrolled
C.Noel Bairey-Merz, MDPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Noninvasive Tests Clinical Trial Eligibility Overview. Trial Name: NCT00573027 — N/A
Cardiovascular Disease Research Study Groups: Single Arm
Cardiovascular Disease Clinical Trial 2023: Noninvasive Tests Highlights & Side Effects. Trial Name: NCT00573027 — N/A
Noninvasive Tests 2023 Treatment Timeline for Medical Study. Trial Name: NCT00573027 — N/A
~278 spots leftby Jan 2040