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

January 28, 2009
May 6, 2013
September 2008
June 2013   (final data collection date for primary outcome measure)
Abnormal cardiac magnetic resonance imaging (CMRI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Subjects will be contacted at 1-year followup.
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 ]
Complete list of historical versions of study NCT00832702 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction
Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction

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.

See the Brief Summary above.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
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.

Non-Probability Sample

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

Cardiovascular Disease
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.
Not Provided
Wei J, Mehta PK, Johnson BD, Samuels B, Kar S, Anderson RD, Azarbal B, Petersen J, Sharaf B, Handberg E, Shufelt C, Kothawade K, Sopko G, Lerman A, Shaw L, Kelsey SF, Pepine CJ, Merz CN. 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. JACC Cardiovasc Interv. 2012 Jun;5(6):646-53. doi: 10.1016/j.jcin.2012.01.023.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
375
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 85 Years
No
Contact: Rosario Ando 310-423-9666 rosario.ando@cshs.org
Contact: Ying Mou, PhD 310-248-7669 ying.mou@cshs.org
United States
 
NCT00832702
IRB# 14906, 5R01HL090957
No
Noel Bairey Merz, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Florida
  • University of Pittsburgh
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai Medical Center
Principal Investigator: Carl J Pepine, MD, MACC University of Florida
Cedars-Sinai Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP