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Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction
This study is currently recruiting participants.
Verified by Cedars-Sinai Medical Center, January 2009
Sponsors and Collaborators: Cedars-Sinai Medical Center
National Institutes of Health (NIH)
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00832702
  Purpose

This research study is designed to investigate the approaches to the 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.

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 1-year followup visit.

Patients will be followed up using phone questionnaires at 6 weeks, 6 months and than annually 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.


Condition Intervention Phase
Coronary Vascular Dysfunction
Procedure: Cardiac MRI
Phase III

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Determine whether CVD predicts abnormalities in Cardiac MRI, whether persistent Cardiac MRI abnormalities predict persistent symptoms of ischemia and whether Cardiac MRI is predictive of adverse outcomes [ Time Frame: Sept. 2008 - Jun. 2012 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood sample will be collected for future genetic studies to better understand heart artery disease by identifing genetic factors that contribute to heart artery disorders, and for extraction and creation of cell lines.


Estimated Enrollment: 375
Study Start Date: September 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Cardiac MRI
    CMRI provides unique clinical utilities including excellent soft tissue characterization and contrast, three-dimensionality, quantitation of blood flow, and overall superior temporal and spatial resolution to image vascular and myocardial abnormalities.
Detailed Description:

See the Brief Summary above.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women undergoing clinically-ordered coronary angiography for suspected ischemia will be recruited.See the inclusion and exclusion criteria for details.

Criteria

Inclusion Criteria:

  • Symptomatic angina or anginal equivalent;
  • Females
  • Aged 18 or older;
  • Competent to give informed consent.

Exclusion Criteria:

  • Obstructive CAD greater than or equal to 50% luminal diameter stenosis in greater than or equal to 1 epicardial coronary artery, acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000), 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;
  • Prior or planned percutaneous coronary intervention or CABG, acute MI;
  • Prior non-cardiac illness with an estimated life expectancy <4 years;
  • Unable to give informed consent;
  • Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
  • Contraindications to CMRI (e.g., AICD, pacemaker, untreatable claustrophobia or known angio-edema).
  • 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 judgement of the operator;
  • Those determined to have flow-obstructing stenosis will be excluded from the overall study.
  • Women with coronary stenosis greater than or equal to 50% in any epicardial coronary artery, assessed visually at the time of angiography, will not be included in the CRT subgroup.
  • Women who are pregnant.
  • Males.
  • Aged <18 years old.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832702

Contacts
Contact: Rosario Ando 3104239666 rosario.ando@cshs.org
Contact: Ying Mou, MEd 3104239678 ying.mou@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Women's Heart Center / PRCC Recruiting
Los Angeles, California, United States, 90048
Contact: Ying Mou, MEd     310-423-9678        
Contact: Rosario Ando     3104239666        
Principal Investigator: C. Noel Bairey Merz, MD            
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai Medical Center
  More Information

Responsible Party: Cedars-Sinai Medical Center ( C. Noel Bairey Merz, MD )
Study ID Numbers: IRB# 14906
Study First Received: January 28, 2009
Last Updated: January 29, 2009
ClinicalTrials.gov Identifier: NCT00832702  
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Cardiac
MRI

Study placed in the following topic categories:
Ischemia

ClinicalTrials.gov processed this record on January 30, 2009