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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Cedars-Sinai Medical Center
Sponsor:
Collaborators:
University of Florida
University of Pittsburgh
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00832702
First received: January 28, 2009
Last updated: May 6, 2013
Last verified: May 2013
  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. 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 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
Cardiovascular Disease
Procedure: Cardiac MRI
Phase 3

Study Type: Observational
Study Design: Time Perspective: 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:
  • Abnormal cardiac magnetic resonance imaging (CMRI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Subjects will be contacted at 1-year followup.


Secondary Outcome Measures:
  • Resource utilization and costs [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    Annual costs will include cardiovascular hospitalizations, coronary revascularizations and angiography, outpatient testing, and visits to generalists, specialists, nurse practitioners/ physician's assistants, or community clinics.

  • Persistent Chest Pain Symptoms [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    Detailed information on chest pain symptoms will include the traditional angina questionnaire and the WISE female angina questionnaire

  • Quality of Life Outcomes [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    Quality of life and functional capacity will be collected using the standard instruments of SAQ and DASI


Biospecimen Retention:   Samples With DNA

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 2013
Estimated Primary Completion Date: June 2013 (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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832702

Contacts
Contact: Rosario Ando 310-423-9666 rosario.ando@cshs.org
Contact: Ying Mou, PhD 310-248-7669 ying.mou@cshs.org

Locations
United States, California
Cedars-Sinai Women's Heart Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ying Mou, PhD    310-248-7669    Ying.Mou@cshs.org   
Contact: Rosario Ando    310-423-9666    Rosario.Ando@cshs.org   
Principal Investigator: C. Noel Bairey Merz, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610-0277
Contact: Carl J Pepine, MD, MACC    352-392-5691    pepincj@medicine.ufl.edu   
Principal Investigator: Carl J Pepine, MD, MACC         
Sponsors and Collaborators
Cedars-Sinai Medical Center
University of Florida
University of Pittsburgh
Investigators
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai Medical Center
Principal Investigator: Carl J Pepine, MD, MACC University of Florida
  More Information

No publications provided by Cedars-Sinai Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00832702     History of Changes
Other Study ID Numbers: IRB# 14906, 5R01HL090957
Study First Received: January 28, 2009
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Cardiac
MRI
Coronary Vascular Dysfunction

Additional relevant MeSH terms:
Cardiovascular Diseases
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014