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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am older than 18 years.
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I experience chest pain or discomfort due to heart issues without major artery blockages.
Select...
I understand the information given to me and can make decisions about my health care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
noninvasive Peripheral Artery Tonometry (PAT) testing and Cardiac Magnetic Resonance (CMR) imaging for the outcome of coronary endothelial dysfunction
Secondary outcome measures
clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
fill out baseline demographic and health/medical history questionnaires, CV risk factors, reasons of diagnosis of ischemia, information of coronary artery, and medication use
undergo clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory (Appendix);
undergo noninvasive Peripheral Artery Tonometry (PAT) testing (Appendix);
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.
have blood and urine testing.
fill out health questionnaires
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
500 Previous Clinical Trials
164,229 Total Patients Enrolled
C.Noel Bairey-Merz, MDPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.My heart's pumping ability is reduced.You have not had a heart condition where the arteries are partially blocked in the past 24 months.I have been diagnosed with a heart condition that blocks blood flow.I have been diagnosed with a type of heart attack or chest pain.I have had or am planning to have heart surgery or had a heart attack in the last 30 days.I have a serious illness, not heart-related, with a life expectancy of less than 4 years.I experience chest pain or discomfort due to heart issues without major artery blockages.I understand the information given to me and can make decisions about my health care.My heart's arteries are partially blocked, but not severely.I have a significant blockage in at least one of my heart's major arteries.I have severe heart failure and am receiving treatment.I need heart valve surgery.My chest pain is not caused by heart artery blockages.I cannot take adenosine or Lexiscan due to health reasons.I am unable to understand and agree to the study's details on my own.I am currently experiencing severe heart failure requiring advanced support.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current quota of participants in this clinical trial?
"Indeed, the clinical trial portal shows that this research is presently recruiting. This investigation was initially publicized on November 1st 2005 and last amended on August 26th 2021. The study requires 634 participants from a single site to complete it."
Answered by AI
Are participants currently being enrolled in this clinical trial?
"Clinicaltrials.gov affirms that this clinical trial is currently seeking participants, with the original listing date being November 1st 2005 and a most recent update on August 26th 2021."
Answered by AI
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