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Early Surgery Versus Conventional Treatment in Infective Endocarditis (EASE)

Primary Purpose

Endocarditis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Valve surgery with removal of vegetations
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endocarditis focused on measuring Endocarditis

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed as infective endocarditis based on modified Duke criteria fulfilling both conditions:

    • severe mitral or aortic regurgitation
    • vegetation length > 10 mm on mitral or aortic valve

Exclusion Criteria:

  • Patients with urgent and emergent indication of surgery based on current guidelines; aortic abscess, moderate to severe heart failure due to valvular regurgitation, periannular complications, fungal endocarditis
  • Prosthetic valve endocarditis
  • Patient without vegetations on echocardiography
  • Patients with ischemic or hemorrhagic stroke within 2 weeks before the admission
  • Patients referred from other hospitals more than 7 days after the appropriate antibiotic treatment of infective endocarditis
  • Patients who were not candidates for surgery based on age > 80 years and coexisting malignancies
  • Patients who did not consent to participate

Sites / Locations

  • Asan Medical Center
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Conventional

Surgery

Arm Description

Conventional Treatment based on current guidelines

Early surgery within 48 hours of randomization

Outcomes

Primary Outcome Measures

Number of Participants With In-hospital Death or Clinical Embolic Events
The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.

Secondary Outcome Measures

All-cause Death
Recurrences of Infective Endocarditis
All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies
Readmission Due to Development of Congestive Heart Failure

Full Information

First Posted
September 8, 2008
Last Updated
April 6, 2015
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00750373
Brief Title
Early Surgery Versus Conventional Treatment in Infective Endocarditis
Acronym
EASE
Official Title
A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There have been no prospective clinical studies in infective endocarditis comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this prospective randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risk of infective endocarditis.
Detailed Description
Infective Endocarditis is still associated with high mortality (16-25%) and high incidence of embolic events (10-49%), and the optimal therapeutic strategy remains unclear. The benefit of surgery was particularly high in patients with abscess formation, periannular complications, and moderate to severe heart failure related to acute mitral or aortic regurgitation. Retrospective studies reported that valve surgery was associated with improved survival, but the benefit of early surgery has not been adequately studied due to inherent treatment biases and significant differences in baseline characteristics. Embolic indications for surgery are more controversial, and surgery is usually performed in cases of recurrent emboli and persist vegetations despite appropriate antibiotic treatment. The combined risk of early surgery and valve prosthesis needs to be balanced against the potential benefit of preventing embolism and improving survival. Risk-benefit balance changes recently to favor early surgery in patients with high embolic risk of endocarditis for the following reasons. Identification of patients with high risk of embolism becomes possible with the use of transesophageal echocardiography. Patients with vegetation length > 10 mm on transesophageal echocardiography have a significantly higher risk of embolization. With advances in surgical technique, urgent surgery is feasible with low operative mortality, and the success rate of valve repair has been increased. To the best of our knowledge, there have been no prospective outcome studies comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this multi-center, prospective, randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risks of infective endocarditis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis
Keywords
Endocarditis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
No Intervention
Arm Description
Conventional Treatment based on current guidelines
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Early surgery within 48 hours of randomization
Intervention Type
Procedure
Intervention Name(s)
Valve surgery with removal of vegetations
Other Intervention Name(s)
early surgery
Intervention Description
Early valve repair or replacement with removal of vegetations within 48 hours of randomization
Primary Outcome Measure Information:
Title
Number of Participants With In-hospital Death or Clinical Embolic Events
Description
The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.
Time Frame
within 6 weeks from the randomization
Secondary Outcome Measure Information:
Title
All-cause Death
Time Frame
up to 6 month after enrollment
Title
Recurrences of Infective Endocarditis
Time Frame
up to 6 months after enrollment
Title
All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies
Time Frame
up to 6 months after enrollment
Title
Readmission Due to Development of Congestive Heart Failure
Time Frame
up to 6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed as infective endocarditis based on modified Duke criteria fulfilling both conditions: severe mitral or aortic regurgitation vegetation length > 10 mm on mitral or aortic valve Exclusion Criteria: Patients with urgent and emergent indication of surgery based on current guidelines; aortic abscess, moderate to severe heart failure due to valvular regurgitation, periannular complications, fungal endocarditis Prosthetic valve endocarditis Patient without vegetations on echocardiography Patients with ischemic or hemorrhagic stroke within 2 weeks before the admission Patients referred from other hospitals more than 7 days after the appropriate antibiotic treatment of infective endocarditis Patients who were not candidates for surgery based on age > 80 years and coexisting malignancies Patients who did not consent to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk-Hyun Kang, MD, PhD
Organizational Affiliation
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27826345
Citation
Kang DH, Lee S, Kim YJ, Kim SH, Kim DH, Yun SC, Song JM, Chung CH, Song JK, Lee JW. Long-Term Results of Early Surgery versus Conventional Treatment for Infective Endocarditis Trial. Korean Circ J. 2016 Nov;46(6):846-850. doi: 10.4070/kcj.2016.46.6.846. Epub 2016 Oct 20.
Results Reference
derived
PubMed Identifier
22738096
Citation
Kang DH, Kim YJ, Kim SH, Sun BJ, Kim DH, Yun SC, Song JM, Choo SJ, Chung CH, Song JK, Lee JW, Sohn DW. Early surgery versus conventional treatment for infective endocarditis. N Engl J Med. 2012 Jun 28;366(26):2466-73. doi: 10.1056/NEJMoa1112843.
Results Reference
derived

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Early Surgery Versus Conventional Treatment in Infective Endocarditis

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