Investigating heart function and blood markers in women with coronary dysfunction
Official title: Women's Ischemia Syndrome Evaluation (WISE) - Coronary Microvascular Dysfunction (CMD) and Heart Failure With Preserved Ejection Fraction (HFpEF)
Run by Cedars-Sinai Medical Center · NCT02582021 · Data updated 2026-11-12
This study is testing how heart function and certain blood markers are related in women with coronary issues and men, to help understand heart failure better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | October 2015 |
| Main results expected | February 2030 |
| Study ends | February 2030 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT02582021 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include symptomatic women aged 18 and older undergoing coronary angiography and individuals hospitalized for HFpEF with preserved ejection fraction.
✕Probably not a fit
Patients with obstructive coronary artery disease or those under 18 years old may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between left ventricular diastolic dysfunction and coronary microvascular dysfunction (CMD) in women and men. It will enroll 220 participants, including symptomatic women undergoing coronary angiography and individuals hospitalized for heart failure with preserved ejection fraction (HFpEF). The study will utilize advanced imaging techniques such as Cardiac Magnetic Resonance Imaging (CMRI) and Coronary Magnetic Resonance Angiography (CMRA) to assess heart function and exclude obstructive coronary artery disease. Additionally, it will analyze blood biomarkers to predict heart failure outcomes and contribute to future precision medicine research.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for women suffering from coronary microvascular dysfunction and heart failure.
How similar studies have gone: Previous studies have established the significance of coronary microvascular dysfunction in women, indicating a promising avenue for further exploration.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: For the new cohort n=120 women undergoing coronary angiography: * Symptomatic angina or anginal equivalent * Age ≥ 18 * Participant is willing to give written informed consent For the cohort n=100 women and men hospitalized for HFpEF (defined by ESC guidelines): * Age ≥ 18 * Signs and symptoms of heart failure * Preserved ejection fraction, left ventricular ejection fraction (LVEF) ≥45% prior to study entry. * Structural evidence of cardiovascular abnormalities: elevated brain naturetic peptide, evidence of abnormal filling or relaxation, left ventricular hypertrophy, or an increased left atrial size * Evidence of elevated filling pressures: LVEDP or PCWP at rest \> 15 mmHg and/or with exercise ≥25 mmHg, exercise E/e' \>13, elevated BNP, or use of diuretic * Participant is willing to give written informed consent Exclusion Criteria: For the new cohort n=120 women undergoing invasive coronary angiography: * Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery * STEMI within 3-7 days post MI, or Acute coronary syndrome/NSTEMI with with symptoms or signs of acute myocardial ischemia within the last 12 to 24 hours prior to the research procedure, as outlined in ACC/AHA guidelines. * Primary valvular heart disease clearly indicating the need for valve repair or replacement * Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or LVEF\<45% * Prior or planned percutaneous coronary intervention or coronary artery bypass grafting for obstructive coronary atherosclerosis * Non-cardiac illness with a life expectancy \< four years * Unable to give informed consent * Chest pain which has an alternative non-ischemic etiology, i.e. pericarditis, pulmonary embolism, pleurisy, pneumonia, esophageal spasm, etc. * Contraindications to CMRI, such as internal cardiac defibrillator, untreatable claustrophobia or known angioedema * Contraindications to adenosine or regadenoson including severe COPD and asthma * End stage renal or liver disease * Women with intermediate coronary stenoses (\>20% but \<50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated fractional flow reserve (FFR) based on the judgment of the operator; those determined to have flow-obstructing stenosis will be excluded. * Documented allergy to gadolinium For the new cohort n=100 women and men hospitalized for HFpEF: * Current LVEF \<45% * STEMI within 3-7 days post MI, or Acute coronary syndrome/NSTEMI with with symptoms or signs of acute myocardial ischemia within the last 12 to 24 hours prior to the research procedure, as outlined in ACC/AHA guidelines. * Acute coronary syndrome (defined by ACC/AHA guidelines, including MI) within 3 months of entry. Patients who have had an MI or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a LVEF ≥45%. * Primary valvular heart disease (moderate regurgitation or\>mild stenosis), primary cardiomyopathies (hypertrophic, infiltrative or restrictive), constrictive pericarditis, high-output heart failure, and right ventricular myopathies) * Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or current acute decompensated HF requiring therapy including due to trauma, infection. * Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) \<10 g/dl, or body mass index (BMI) \> 40 kg/m2. * Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP \>150 mmHg and \<180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs. * Prior or planned percutaneous coronary intervention or coronary artery bypass grafting for obstructive coronary atherosclerosis * Non-cardiac illness with a life expectancy \< four years * Unable to give informed consent * Contraindications to CMRI, such as internal cardiac defibrillator, untreatable claustrophobia or known angioedema * Contraindications to adenosine or regadenoson including severe COPD and asthma. * Obstructive stenoses (≥50% luminal diameter stenosis assessed visually at the time of research CTA) will be excluded from further analyses. Subjects with obstructive or borderline obstructive coronary CTA stenoses will be referred to their clinicians for further clinical care and clinical decision making. End stage renal or liver disease
Where it's running
-
Cedars-Sinai Women's Heart Center
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: C. Noel Bairey Merz, MD, FACC — Cedars-Sinai Medical Center
- Study coordinator: BSWHC Research, MS
- Email: bswhc.research@cshs.org
- Phone: 310-423-9666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.