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Trial record 1 of 17 for:    Recruiting, Not yet recruiting, Available Studies | "Rheumatic Fever"
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Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Penicillin Secondary Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03183180
Recruitment Status : Not yet recruiting
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):
Dr. Amir Ben-Tov, Assuta Hospital Systems

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.

Condition or disease Intervention/treatment
Secondary Cardiac Damage in Rheumatic Fever Diagnostic Test: Echocardiogram

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Adherence to Penicillin Secondary Prophylaxis
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Penicillins

Intervention Details:
  • Diagnostic Test: Echocardiogram
    Current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination

Primary Outcome Measures :
  1. Cardiac function including vulvar involvement [ Time Frame: 60 days ]
    Cardiac morphology and function measured by echocardiography

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 21 years who were diagnosed with RF (before age 18 years) acoording to the computerized database.

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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Responsible Party: Dr. Amir Ben-Tov, Medical Director online centers, Assuta Hospital Systems Identifier: NCT03183180     History of Changes
Other Study ID Numbers: 0137-16-ASMC
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rheumatic Fever
Neoplasm Metastasis
Rheumatic Diseases
Neoplastic Processes
Pathologic Processes
Body Temperature Changes
Signs and Symptoms
Musculoskeletal Diseases
Connective Tissue Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Joint Diseases
Anti-Bacterial Agents
Anti-Infective Agents