Women With Chest Pain and Normal Coronary Arteries Study

This study has been terminated.

( Terminated due to departure of PI from institution. )

Study NCT00743197 Information provided by Northwestern University

First Received on August 26, 2008. Last Updated on November 30, 2011 History of Changes

Results First Received: September 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Chest Pain
Interventions:	Drug: Aspirin Drug: Lisinopril Drug: Simvastatin Drug: Lovaza Behavioral: Therapeutic Lifestyle Changes

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Usual Care Group	USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
Medical Treatment Group	TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.

Participant Flow: Overall Study

	Usual Care Group	Medical Treatment Group
STARTED	1	2
COMPLETED	0	0
NOT COMPLETED	1	2
Study terminated due to departure of PI.	1	2

Baseline Characteristics

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Reporting Groups

	Description
Usual Care Group	USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
Medical Treatment Group	TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.

Baseline Measures

	Usual Care Group	Medical Treatment Group	Total
Number of Participants [units: participants]	1	2	3
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	1	2	3
>=65 years	0	0	0
Gender [units: participants]
Female	1	2	3
Male	0	0	0
Region of Enrollment [units: participants]
United States	1	2	3

Outcome Measures

1. Primary:

Effectiveness of Therapy Compared to Usual Care, in Those Women With Chest Pain (CP), Reversible Ischemia by Stress Testing and Nonobstructive Coronary Artery Disease (CAD) by Angiography Who Are Found to Have Coronary Endothelial Dysfunction (CED). [ Time Frame: 1 year ]

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2. Secondary:

The Role and Function of Endothelial Progenitor Cells (EPCs) in the Presence of Proven Endothelial Dysfunction and the Response of EPCs to Medical Therapy for Endothelial Dysfunction. [ Time Frame: 1 year ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated due to departure of PI; all work including analyses ceased upon departure.In addition,study end points were based on changes b/w groups treatment vs. usual care) at 12 mo follow up- none of the subjects completed the Mo 12 visit.

Results Point of Contact:

Name/Title: Dr. Martha Gulati, Principal Investigator
Organization: Northwestern University
phone: 312-695-4965
e-mail: mgulati@nmh.org

No publications provided

Responsible Party:	Anna Huskin, Northwestern University
ClinicalTrials.gov Identifier:	NCT00743197 History of Changes
Other Study ID Numbers:	AB-08-002
Study First Received:	August 26, 2008
Results First Received:	September 13, 2011
Last Updated:	November 30, 2011
Health Authority:	United States: Institutional Review Board