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

Status:	Active, not recruiting
Conditions:	Peripheral Vascular Disease
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 85
Updated:	3/8/2019
Start Date:	September 17, 2008
End Date:	August 31, 2020

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.

See Brief Summary above.

Inclusion Criteria:

1. Symptomatic angina or anginal equivalent;

2. Aged 18 years or older;

3. No obstructive CAD at coronary angiography (performed within the previous 24 months).

4. Competent to give informed consent.

Exclusion Criteria:

1. Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery,

2. Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000),

3. Primary valvular heart disease clearly indicating the need for valve repair or
replacement;

4. Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic
balloon support;

5. Prior or planned percutaneous coronary intervention or CABG,

6. Acute MI;

7. Prior non-cardiac illness with an estimated life expectancy < 4 years;

8. Unable to give informed consent;

9. Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal
spasm);

10. Contraindications to CMRI (e.g., AICD, pacemaker, untreatable claustrophobia or known
angio-edema).

11. Contraindications to adenosine or Regadenoson (Lexiscan)

12. Women with intermediate coronary stenoses (> 20% but < 50% luminal diameter stenosis
assessed visually at the time of angiography) will undergo clinically indicated IVUS
testing based on the judgment of the operator; those determined to have
flow-obstructing stenosis will be excluded from the overall study.

13. Participation in a research study that conflicts with the current WISE study.

14. Women with coronary stenosis ≥ 50% in any epicardial coronary artery, assessed
visually at the time of angiography, will not be included in the CRT subgroup.

We found this trial at

sites

University of Florida

Gainesville, Florida 32610

(352) 392-3261