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| Sponsored by: |
St. Vincent's Medical Center |
|---|---|
| Information provided by: | St. Vincent's Medical Center |
| ClinicalTrials.gov Identifier: | NCT00273637 |
Purpose
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 |
|---|
|
Cardiomyopathy Pregnancy-Associated Cardiomyopathy Heart Failure |
| Study Type: | Observational |
| Study Design: | Natural History, Cross-Sectional, Defined Population, Retrospective Study |
| Official Title: | Pregnancy Related Cardiomyopathy Enrollment and Lessons in Web-Based Recruitment (PRiCELESS) |
| Estimated Enrollment: | 175 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | January 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| Contact: Jordan G Safirstein, MD | 212 604-2228 | priceless@svcmcny.org |
| 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 | |
| Principal Investigator: | Jordan G Safirstein, MD | Saint Vincent's Catholic MEdical Center |
| Study Director: | Cezar Staniloae, MD, FACC | SVCMC |
More Information
| Study ID Numbers: | STVincentH |
| Study First Received: | January 5, 2006 |
| Last Updated: | May 25, 2006 |
| ClinicalTrials.gov Identifier: | NCT00273637 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
heart failure peripartum cardiomyopathy pregnancy-associated cardiomyopathy pregnancy complications nonischemic cardiomyopathy |
|
Heart Failure Heart Diseases Pregnancy Complications Cardiomyopathies |
|
Heart Failure Heart Diseases Cardiovascular Diseases Cardiomyopathies |
