Trial record 3 of 1912 for:    heart disease and women

Heart Disease of the Small Arteries in Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Cedars-Sinai Medical Center
Sponsor:
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00573027
First received: December 12, 2007
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

Women suffer disproportionately than men from coronary heart disease in the small vessels (arterioles) compared to the large vessels (arteries). This results in delays in diagnosis, missed opportunities for treatment, and likely contributes to the increased death rate from coronary heart disease in women compared to men. Current testing for small vessel disease is invasive in the cardiac catheterization laboratory and is not performed routinely. Accordingly, women with this condition are routinely either falsely reassured, or misdiagnosed as another non-cardiac condition.

New imaging and noninvasive technology exists that may improve this situation. Measurement of endothelial function, using non-invasive tonometry testing can detect the abnormality most associated with coronary heart disease, endothelial dysfunction. Imaging techniques such as cardiac magnetic resonance imaging can now show the subendocardial layer of the heart, where the small vessel abnormality exists. These techniques have not been tested to determine if they can be used to diagnose and treat the small vessel coronary heart disease condition.

40 women undergoing coronary angiography with non-obstructive coronary artery disease will be enrolled. They will receive invasive provocative acetylcholine testing in the cardiac catheterization laboratory, followed by noninvasive Peripheral Artery Tonometry (PAT)testing, and cardiac magnetic resonance testing. Correlation analyses will be analyzed with regard to the predictive value of the noninvasive testing for the outcome of small vessel disease by the invasive acetylcholine testing. The data from this study will be pilot data for a larger prospective study. These studies an important step toward better understanding, and safer diagnosis of the coronary heart disease that is prevalent in over 9 million American women today.


Condition Intervention Phase
Heart Disease
Procedure: noninvasive tests
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Heart Disease of the Small Arteries in Women

Resource links provided by NLM:


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

Primary Outcome Measures:
  • noninvasive Peripheral Artery Tonometry (PAT) testing and Cardiac Magnetic Resonance (CMR) imaging for the outcome of coronary endothelial dysfunction [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 634
Study Start Date: November 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm Procedure: noninvasive tests
clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory; Peripheral Artery Tonometry (PAT) testing; Cardiac Magnetic Resonance (CMR) imaging.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with signs and symptoms of myocardial ischemia (chest pain, abnormal stress testing, abnormal noninvasive testing) in the absence of obstructive coronary artery disease (<50% luminal obstruction in one or more coronary arteries on angiography).

Exclusion Criteria:

  • Contraindications to angiography and invasive coronary function testing with acetylcholine.
  • Contraindications to withholding nitrates, calcium channel agents, ACE/ARB agents for 48 hours prior to testing.
  • Life expectancy less than 6 months
  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: NCT00573027

Contacts
Contact: Chrisandra Shufelt, MD 310-423-9680 ShufeltC@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   
Principal Investigator: Noel Bairey-Merz, MD         
Sub-Investigator: Saible Kar, MD         
Sub-Investigator: Raj Makkar, MD         
Sub-Investigator: Dan Berman, MD         
Sub-Investigator: Leslee Shaw, MD         
Sub-Investigator: Louise Thompson, MBChB         
Sub-Investigator: Rola Saouf, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Noel Bairey-Merz, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00573027     History of Changes
Other Study ID Numbers: IRB 8221
Study First Received: December 12, 2007
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
microvascular dysfunction
Microvascular

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014