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Registry and Survey of Women With Pregnancy Related Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT00273637
Recruitment Status : Unknown
Verified October 2005 by St. Vincent's Medical Center.
Recruitment status was:  Recruiting
First Posted : January 9, 2006
Last Update Posted : May 26, 2006
Sponsor:
Information provided by:
St. Vincent's Medical Center

Study Description
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Brief Summary:
The goal of this study is to better characterize peripartum cardiomyoapthy or pregnancy-related cardiomyopathy by enrolling as many PPCM survivors as possible using both direct and web-based methods of recritment. Patients will anser a questionnaire regarding the onset, progression, treatment and follow-up of their diagnosis as well as the psychosocial aspects of PPCM.

Condition or disease
Cardiomyopathy Pregnancy-Associated Cardiomyopathy Heart Failure

Detailed Description:

The design of our study will utilize web-based recruitment methods with internet-based support groups for PPCM e.g. www.AMothersHeart.org (www.amothersheart.org/index.html). The directors of these websites will facilitate contact between our research staff and the several hundred members of these web sites.

An introductory letter will be posted on the website introducing the cardiovascular research team and describing the purpose, basic methods, and goals of our study. Website members who desire to participate can respond to a dedicated e-mail address we have set up and provide contact information so that we may get informed consent via telephone or mailed written consent. A telephone number will also be provided for participants so that they may call with questions regarding the study. Patients will then receive a questionnaire addressing our study goals. Questions will focus on obtaining family and social history, characterizing presenting symptoms, initial management, and clinical course following delivery of the fetus including extent of cardiovascular follow-up, date of echocardiograms performed, medications, and psychosocial support, if provided.


Study Design
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Study Type : Observational
Enrollment : 175 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
Official Title: Pregnancy Related Cardiomyopathy Enrollment and Lessons in Web-Based Recruitment (PRiCELESS)
Study Start Date : October 2005
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be eligible for inclusion if diagnosed with PPCM after January 1, 1994. Patients must be above the age of 18 years old with no prior cardiac history and no history of chronic drug or alcohol abuse. Diagnosis of PPCM must have been made prior after the 28th week of gestation and up to 6 months postpartum. Patients must have echocardiographic data confirming left ventricular systolic dysfunction by either depressed shortening fraction or depressed ejection fraction.

Exclusion Criteria:

Patients with an identifiable etiology for their heart failure will be excluded.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273637


Contacts
Contact: Jordan G Safirstein, MD 212 604-2228 priceless@svcmcny.org

Locations
United States, New York
Saint Vincent's Catholic Medical Center Recruiting
New York, New York, United States, 10011
Contact: Eileen Hermance, RN    212-604-2228    ehermance@svcmcny.org   
Principal Investigator: Jordan G Safirsteinn, MD         
Sub-Investigator: Joonun Choi, MD         
Sub-Investigator: Angela Ro, MD         
Sub-Investigator: Sree Grandhi, MD         
Sub-Investigator: Eileen Hermance, RN         
Sub-Investigator: Cezar Staniloae, MD< FACC         
Sponsors and Collaborators
St. Vincent's Medical Center
Investigators
Principal Investigator: Jordan G Safirstein, MD Saint Vincent's Catholic MEdical Center
Study Director: Cezar Staniloae, MD, FACC SVCMC
More Information
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Additional Information:
Website support group intimately involved in the enrollment and education of our study participants  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00273637     History of Changes
Other Study ID Numbers: STVincentH
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: May 26, 2006
Last Verified: October 2005

Keywords provided by St. Vincent's Medical Center:
heart failure
peripartum cardiomyopathy
pregnancy-associated cardiomyopathy
pregnancy complications
nonischemic cardiomyopathy

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases