Study Stopped
Slow recruitment
Stress Echo for Ischemic Mitral Valve Surgery
SURVIVE
1 other identifier
interventional
400
1 country
1
Brief Summary
Comparison patients with CABG alone vs. CABG+mitral surgery with non-massive ischaemic mitral regurgitation (IMR) depending on stress echo data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 30, 2019
CompletedFirst Posted
Study publicly available on registry
July 17, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedOctober 20, 2022
October 1, 2022
5 years
June 30, 2019
October 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
myocardial infarction
myocardial infarction
during 3 year
all-cause death
all-cause death
during 3 year
new hospital readmission
new hospitalization
during 3 year from including
re-operation
percutaneous coronary intervention, coronary bypass surgery, heart transplant
during 3 year
cardiac death
cardiac death
during 3 year
Secondary Outcomes (9)
physical capacity
Change from Baseline of physical capacity in Watts at 12 months, at 3 years
end diastolic volume of left ventricle
Change from Baseline of end diastolic volume of left ventricle at 12 months, at 3 years
left atrium volume
Change from Baseline of left atrium volume at 12 months, at 3 years
ejection fraction at rest and during stress echo
Change from Baseline of ejection fraction at 12 months, at 3 years
effective regurgitant orifice
Change from Baseline at 12 months, at 3 years
- +4 more secondary outcomes
Study Arms (6)
CABG/increasing MR
NO INTERVENTIONnon-massive IMR with increasing IMR during exercise - CABG only
CABG+mitral surgery (MS)/increasing MR
EXPERIMENTALnon-massive IMR with increasing IMR during exercise - CABG+ mitral surgery
CABG/non-increasing MR
NO INTERVENTIONnon-massive IMR non-increasing IMR during exercise - CABG only
CABG+MS/non-increasing MR
EXPERIMENTALnon-massive IMR non-increasing IMR - CABG+ mitral surgery
Control 1
OTHERmassive IMR at rest without increasing during exercise - CABG+ mitral surgery
Control 2
OTHERmassive IMR at rest with increasing during exercise - CABG+ mitral surgery
Interventions
Guidelines approved mitral surgery
Eligibility Criteria
You may qualify if:
- Ischemic MR, ERO≥0.2 cm2 and RV≥30 ml.
- Indication for CABG
You may not qualify if:
- Unwillingness to give informed consent and to enter a regular follow-up program.
- Contraindications for SE.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Petersburg State University
Saint Petersburg, Russia
Study Officials
- PRINCIPAL INVESTIGATOR
Dmitry Shmatov, MD, PhD
Saint Petersburg State University, Russia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director for science
Study Record Dates
First Submitted
June 30, 2019
First Posted
July 17, 2019
Study Start
January 1, 2020
Primary Completion
December 31, 2024
Study Completion (Estimated)
December 31, 2027
Last Updated
October 20, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 3 year
Study Protocol, Clinical study report