NCT02232048

Brief Summary

Patients hospitalized in internal medicine departments are given corticosteroid treatment according clinical indications. Patients receive treatment at different dosage levels and in different preparations according to clinical indications. This study will investigate how corticosteroids effect the heart and specifically, longitudinal strain.

Trial Health

43
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 Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

August 20, 2014

Last Update Submit

September 8, 2014

Conditions

Myocardial Function

Outcome Measures

Primary Outcomes (1)

  • Change in Heart Function

    Heart contraction and specifically its longitudinal strain will be examined using Transthoracic Echocardiogram (TTE) before, during and after corticosteroid treatment. TTE reveals changes in contraction in the right and left ventricle and septum.

    Two years

Study Arms (1)

Corticosteroid Treatment

Patients in the internal medicine department who are being treated with corticosteroids will undergo Transthoracic Echocardiogram to determine change in heart function.

Other: Transthoracic Echocardiogram

Interventions

Transthoracic EchocardiogramOTHER
Also known as: Transthoracic Echocardiogram using a VIVID 6 device
Corticosteroid Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients being treated with corticosteroids for various clinical indications who have been hospitalized in the internal medicine department of the Hillel Yaffe Medical Center.

You may qualify if:

  • Stable patients able to undergo Transthoracic Echocardiogram
  • Patients beginning treatment with corticosteroids

You may not qualify if:

  • Pregnant
  • Patients recently or chronically treated with corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Central Study Contacts

Nina Avshovich, MD

CONTACT

972-4-630-835ninaa@hy.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2014

First Posted

September 4, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

IL(1)