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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01406353 |
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Date of registration:
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28/07/2011 |
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Primary sponsor: |
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Public title:
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Early Percutaneous Mitral Intervention in Asymptomatic Moderate Mitral Stenosis
MITIGATE |
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Scientific title:
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Early Percutaneous Mitral Intervention Versus Conventional Management in Asymptomatic Moderate Mitral Stenosis |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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166 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01406353 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Duk-Hyun Kang, MD, PhD |
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Address:
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Telephone:
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82-2-3010-3166 |
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Email:
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dhkang@amc.seoul.kr |
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Affiliation:
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Name:
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Duk-Hyun Kang, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asan Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- asymptomatic patients with moderate MS who are potential candidates for early
percutaneous mitral commissurotomy
Exclusion Criteria:
- patients with exertional dyspnea
- total echocardiographic score > 10
- moderate to severe mitral regurgitation
- left atrial thrombi
- significant aortic valve disease,
- left ventricle (LV) ejection fraction (EF) <50%
- Doppler-estimated pulmonary artery systolic pressure >50 mmHg
- those who were not candidates for early intervention based on age > 70 years or the
presence of coexisting malignancies
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Moderate Mitral Stenosis
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Intervention(s)
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Procedure: Percutaneous Mitral Commissurotomy
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Primary Outcome(s)
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Composite of cardiovascular event
[Time Frame: Participants will be followed for the duration of the trial, an expected average of 3 years]
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Secondary Outcome(s)
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all-cause death and each component of cardiovascular event
[Time Frame: Participants will be followed for the duration of the trial, an expected average of 3 years]
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Secondary ID(s)
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2011-0432
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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