NCT03183180

Brief Summary

According to American Heart Association criteria, patients who have had Rheumatic Fever (RF) should be treated with antibiotic prophylaxis. Continuous prophylaxis is recommended in patients with well-documented histories of RF and in those with evidence of rheumatic heart disease. There is a limited data regarding adherence of patients to treatment and efficacy of treatment. In this study, patients with RF who are older than 21 years will be collected from a computerized database of 'Maccabi Healthcare Services', one of the biggest Israeli Health Funds. Patients will be assigned to the study after obtaining informed consent. Previous adherence to antibiotic prophylaxis will be examined according to computerized database of drugs which were issued to the patient since RF diagnosis. Past history of cardiac involvement, including past Echocardiograms, will be collected from computerized database. In addition, the current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

June 7, 2017

Last Update Submit

June 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cardiac function including vulvar involvement

    Cardiac morphology and function measured by echocardiography

    60 days

Interventions

EchocardiogramDIAGNOSTIC_TEST

Current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older than 21 years who were diagnosed with RF (before age 18 years) acoording to the computerized database.

You may qualify if:

  • \- Patients older than 21 years who were diagnosed with RF (before age 18 years) according to the computerized database.

You may not qualify if:

  • patients with other rheumatic disease diagnosed before RF diagnosis
  • patients with other cardiac disease diagnosed before RF diagnosis
  • patients with neoplastic disease diagnosed before RF diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director online centers

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 9, 2017

Study Start

June 1, 2017

Primary Completion

December 1, 2017

Study Completion

May 1, 2019

Last Updated

June 9, 2017

Record last verified: 2017-06