๐ฌIn plain words
What the trial is, and whether it could suit you
The Women's Ischemia Study Evaluation (WISE), a cohort study of over 1000 women, has made many contributions to the understanding of cardiovascular disease. A milestone acknowledged in the 2011 AHA Herrick Lecture is the role of Coronary Microvascular Dysfunction (CMD) in women with symptoms/signs of ischemia without obstructive coronary artery disease (CAD). While in 1996, CMD was considered "an imaging artifact", in 2013, it is a widely accepted as a pathophysiologic process requiring systematic cohesive scientific pursuit. CMD is prevalent, associated with adverse clinical outcomes, poor quality of life and healthcare costs rivaling obstructive CAD. There are 2-3 million US women with CMD, and 100,000 new cases projected annually placing CMD prevalence, morbidity and costs higher than all female reproductive cancers combined.
Among women with ischemia, preserved ejection fraction and
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
For the new cohort n=120 women undergoing coronary angiography:
* Symptomatic angina or anginal equivalent
* Age โฅ 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 โฅ 18
* Signs and symptoms of heart failure
* Preserved ejection fraction, left ventricular ejection fraction (LVEF) โฅ45% 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 โฅ25 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 โฅ 50% luminal diameter stenosis in โฅ 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 โฅ45%.
* 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) โฅ 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 (โฅ50% 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