NCT00832702

Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction

Active, enrolled Last updated 19 September 2025

What this trial tests

trial testing Cardiac MRI in Cardiovascular Disease in 433 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 September 2008

Primary endpoint
15 September 2015

31 August 2051

Quick facts

Lead sponsor	Cedars-Sinai Medical Center
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	433
Start date	17 September 2008
Primary completion	15 September 2015
Estimated completion	31 August 2051
Sites	2 locations across United States

Drugs / interventions tested

• Cardiac MRI

Conditions studied

• Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

Cedars-Sinai Medical Center

Who can join

Adults 18 to 85, female only, with Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research study is designed to investigate the approaches to noninvasive detection and assessment of coronary vascular dysfunction in women by comparing the testing results from the invasive standard care diagnostic procedure Angiogram and from the additional noninvasive diagnostic procedure CMR Imaging. The investigators want to specifically study 375 female patients who have signs or symptoms suggestive of heart disease but don't have obstructive coronary artery disease. Two study sites (Cedars-Sinai Medical Center and University of Florida) are recruiting participants.

The standard of care procedures include demographics, review of recent clinical symptoms, review of medications being taken, a physical exam, pre-angiogram blood collection, chest x-ray, ECG and heart angiogram. The research procedures for this study are the cold pressor testing, blood/urine collection, health questionnaire, the post-angiogram ECG and cardiac MRI.

Patients will be asked to undergo heart angiogram testing to test for abnormalities in their heart arteries. If the heart angiogram shows that the patients do not have blockages in major heart arteries, then the patients will have coronary flow reserve measurement test (as part of the heart angiogram) to determine whether the patients have abnormally functioning of the small heart arteries. This test will be performed by infusing the three drugs: adenosine, acetylcholine and nitroglycerin. The three drugs are naturally occurring substances and have been used for routine heart angiograms.

Cardiac Magnetic Resonance (CMR) imaging may help us more easily and non-invasively detect abnormalities in the inner layer of the heart muscle resulting from the abnormal function of the heart arteries. All the 375 participants will undergo baseline CMR imaging test and a subgroup of 200 participants will undergo a second CMR imaging test at their at least 1-year followup visit.

Patients will be followed up using phone questionnaires at 6 weeks, 6 months for 5 years, and than annually for 20 years thereafter. Other procedures in this study include obtaining informed consent, review of demographics, physical examination, ECG, blood and urine tests, clinical symptoms, medications, questionnaires, etc. The core laboratories include Blood, Lipoprotein, Chemistry Core Lab, Reproductive Hormone Core Lab, Inflammatory Marker Core Lab, Oxidative Stress Core Lab, and Angiographic Core Lab. Additionally, GCRC at Cedars Sinai will process, store and ship samples as needed/required.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cardiac magnetic resonance myocardial perfusion reserve index is reduced in women with coronary microvascular dysfunction. A National Heart, Lung, and Blood Institute-sponsored study from the Women's Ischemia Syndrome Evaluation.
   Thomson LE, Wei J, Agarwal M, Haft-Baradaran A, et al · · 2015 · cited 189× · PMID 25801710 · DOI 10.1161/circimaging.114.002481
2. Safety of coronary reactivity testing in women with no obstructive coronary artery disease: results from the NHLBI-sponsored WISE (Women's Ischemia Syndrome Evaluation) study.
   Wei J, Mehta PK, Johnson BD, Samuels B, et al · · 2012 · cited 171× · PMID 22721660 · DOI 10.1016/j.jcin.2012.01.023
3. Autologous CD34+ Stem Cell Therapy Increases Coronary Flow Reserve and Reduces Angina in Patients With Coronary Microvascular Dysfunction.
   Henry TD, Bairey Merz CN, Wei J, Corban MT, et al · · 2022 · cited 42× · PMID 35067072 · DOI 10.1161/circinterventions.121.010802
4. Design, methodology and baseline characteristics of the Women's Ischemia Syndrome Evaluation-Coronary Vascular Dysfunction (WISE-CVD).
   Quesada O, AlBadri A, Wei J, Shufelt C, et al · · 2020 · cited 26× · PMID 31884245 · DOI 10.1016/j.ahj.2019.11.017
5. Myocardial Scar Is Prevalent and Associated With Subclinical Myocardial Dysfunction in Women With Suspected Ischemia But No Obstructive Coronary Artery Disease: From the Women's Ischemia Syndrome Evaluation-Coronary Vascular Dysfunction Study.
   Wei J, Bakir M, Darounian N, Li Q, et al · · 2018 · cited 26× · PMID 29459474 · DOI 10.1161/circulationaha.117.031999
6. Adverse Pregnancy Outcomes Are Associated with Reduced Coronary Flow Reserve in Women With Signs and Symptoms of Ischemia Without Obstructive Coronary Artery Disease: A Report from the Women's Ischemia Syndrome Evaluation-Coronary Vascular Dysfunction Study.
   Park K, Quesada O, Cook-Wiens G, Wei J, et al · · 2020 · cited 20× · PMID 31859580 · DOI 10.1089/jwh.2019.7925
7. Left ventricular circumferential strain and coronary microvascular dysfunction: A report from the Women's Ischemia Syndrome Evaluation Coronary Vascular Dysfunction (WISE-CVD) Project.
   Tamarappoo B, Samuel TJ, Elboudwarej O, Thomson LEJ, et al · · 2021 · cited 17× · PMID 33202262 · DOI 10.1016/j.ijcard.2020.11.006
8. Coronary Vascular Function and Cardiomyocyte Injury: A Report From the WISE-CVD.
   AlBadri A, Wei J, Quesada O, Mehta PK, et al · · 2020 · cited 17× · PMID 33028098 · DOI 10.1161/atvbaha.120.314260