Registry and Survey of Women With Pregnancy Related Cardiomyopathy

Sponsor
St. Vincent's Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00273637
Collaborator
(none)
175
1
3
57.9

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Other
    Official Title:
    Pregnancy Related Cardiomyopathy Enrollment and Lessons in Web-Based Recruitment (PRiCELESS)
    Study Start Date :
    Oct 1, 2005
    Study Completion Date :
    Jan 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 50 Years
      Sexes 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

      Locations

      Site City State Country Postal Code
      1 Saint Vincent's Catholic Medical Center New York New York United States 10011

      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

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00273637
      Other Study ID Numbers:
      • STVincentH
      First Posted:
      Jan 9, 2006
      Last Update Posted:
      May 26, 2006
      Last Verified:
      Oct 1, 2005

      Study Results

      No Results Posted as of May 26, 2006