- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273637
Registry and Survey of Women With Pregnancy Related Cardiomyopathy
Pregnancy Related Cardiomyopathy Enrollment and Lessons in Web-Based Recruitment (PRiCELESS)
Study Overview
Status
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 Type
Enrollment
Contacts and Locations
Study Contact
- Name: Jordan G Safirstein, MD
- Phone Number: 212 604-2228
- Email: priceless@svcmcny.org
Study Locations
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New York
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New York, New York, United States, 10011
- Recruiting
- Saint Vincent's Catholic Medical Center
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Contact:
- Eileen Hermance, RN
- Phone Number: 212-604-2228
- Email: ehermance@svcmcny.org
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Principal Investigator:
- Jordan G Safirsteinn, MD
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Sub-Investigator:
- Joonun Choi, MD
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Sub-Investigator:
- Angela Ro, MD
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Sub-Investigator:
- Sree Grandhi, MD
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Sub-Investigator:
- Eileen Hermance, RN
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Sub-Investigator:
- Cezar Staniloae, MD< FACC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jordan G Safirstein, MD, Saint Vincent's Catholic Medical Center
- Study Director: Cezar Staniloae, MD, FACC, SVCMC
Publications and helpful links
General Publications
- Ro A, Frishman WH. Peripartum cardiomyopathy. Cardiol Rev. 2006 Jan-Feb;14(1):35-42. doi: 10.1097/01.crd.0000174805.68081.f7.
- Fett JD, Christie LG, Carraway RD, Murphy JG. Five-year prospective study of the incidence and prognosis of peripartum cardiomyopathy at a single institution. Mayo Clin Proc. 2005 Dec;80(12):1602-6. doi: 10.4065/80.12.1602.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STVincentH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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