Condition or disease | Intervention/treatment | Phase |
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Ischemic Mitral Regurgitation | Procedure: Mitral surgery | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Stress Echo for Ischemic Mitral Valve Surgery |
Actual Study Start Date : | January 1, 2020 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2027 |
Arm | Intervention/treatment |
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No Intervention: CABG/increasing MR
non-massive IMR with increasing IMR during exercise - CABG only
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Experimental: CABG+mitral surgery (MS)/increasing MR
non-massive IMR with increasing IMR during exercise - CABG+ mitral surgery
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Procedure: Mitral surgery
Guidelines approved mitral surgery
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No Intervention: CABG/non-increasing MR
non-massive IMR non-increasing IMR during exercise - CABG only
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Experimental: CABG+MS/non-increasing MR
non-massive IMR non-increasing IMR - CABG+ mitral surgery
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Procedure: Mitral surgery
Guidelines approved mitral surgery
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Control 1
massive IMR at rest without increasing during exercise - CABG+ mitral surgery
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Procedure: Mitral surgery
Guidelines approved mitral surgery
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Control 2
massive IMR at rest with increasing during exercise - CABG+ mitral surgery
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Procedure: Mitral surgery
Guidelines approved mitral surgery
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Angela Zagatina, MD, PhD | +79213297087 | zag_angel@yahoo.com |
Russian Federation | |
St. Petersburg State University | Recruiting |
Saint Petersburg, Russian Federation | |
Contact: Angela Zagatina, MD, PhD |
Principal Investigator: | Dmitry Shmatov, MD, PhD | Saint Petersburg State University, Russia |
Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | June 30, 2019 | ||||||||||||||
First Posted Date ICMJE | July 17, 2019 | ||||||||||||||
Last Update Posted Date | September 25, 2020 | ||||||||||||||
Actual Study Start Date ICMJE | January 1, 2020 | ||||||||||||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Stress Echo for Ischemic Mitral Valve Surgery | ||||||||||||||
Official Title ICMJE | Stress Echo for Ischemic Mitral Valve Surgery | ||||||||||||||
Brief Summary | Comparison patients with CABG alone vs. CABG+mitral surgery with non-massive ischaemic mitral regurgitation (IMR) depending on stress echo data. | ||||||||||||||
Detailed Description |
Chronic ischaemic mitral regurgitation (IMR) is a frequent complication of coronary artery disease (CAD), and is associated with a poor prognosis and outcome. The role of concomitant mitral valve surgery for IMR in patients undergoing coronary artery bypass grafting (CABG) remains controversial. After myocardial infarction IMR is associated with poor outcome and prognosis with double mortality rates, it reduces survival following surgical or percutaneous revascularization. However, there is no consensus on the cut-off value of IMR. The thresholds to define severe secondary mitral regurgitation are need to be evaluated with regards to their impact on prognosis after mitral valve intervention. The European guidelines is defined effective regurgitant orifice (ERO)-0.2 cm2 and regurgitant volume (RV)-30ml, as the threshold for severe IMR, because of severe prognosis of this group. Whereas American guidelines are defined it as ERO-0.4 cm2 and RV-60ml, as it was no evidence to impact intervention on the IMR with ERO-0.2 cm2 and RV-30ml. Partly it's explained by the dynamic nature of the secondary MR. About 30% of patients from the group with non-massive regurgitation at rest, have dramatically increasing it during exercise. However, some patient have not changes or decreasing IMR during exercise and, probably, they have not such a negative impact on the hemodynamic by IMR. The pervious comparative studies, that were the base for recommendations did not differ the patients with and without changes IMR during exercise. The current guidelines doesn't support the stress echo (SE) exams before operation for assessing necessity in mitral valve operation. It's due to lack of information that prove of influence for survival after surgery depending on IMR dynamic parameters. IMR study hypothesis: Stress echocardiography data, including ERO, RV, pulmonary pressure (PA) pressure, beta-lines - B-lines, contractile reserve, could be indications for mitral valve intervention in patient with CAD and chronic secondary mitral regurgitation, undergoing CABG. The patients of the group with non-massive (ERO-0.2 cm2 and RV-30ml) IMR have positive effect by mitral surgery if they have increasing IMR during exercise test. The group with massive IMR (ERO≥0.4 cm2 and RV≥60 ml) will be better according clinic, echo, stress echo results in comparison with non-massive non-operated subgroup. Aim: To assess the value of stress echo testing for ischemic mitral surgery indication in patients undergoing CABG. Inclusion criteria for all projects are:
Exclusion criteria for all projects are:
Methods and design:
Secondary end-points: physical capacity (changes in Watts, minutes of stress echocardiography), EDV, left atrium volume, EF at rest and during SE, ERO, RV, PA pressure, B-lines, contractile reserve at rest and during exercise in comparison with pre-operative data. Expected results. Group 1, CABG - subgroup, CABG+mitral surgery subgroup. It's expected the improvement of physical capacity (changes in Watts, minutes of stress echocardiography), EDV, left atrium volume, EF at rest and during SE, ERO, RV, PA pressure, B-lines, contractile reserve at rest and during exercise in comparison with pre-operative data in CABG+mitral surgery subgroup already in 1-year follow-up. It's expected the improvement of physical capacity (changes in Watts, minutes of stress echo), EDV, left atrium volume, EF at rest and during stress echo, ERO, RV, PA pressure, B-lines, contractile reserve at rest and during exercise in comparison with CABG-subgroup already in 1-year follow-up. It's expected that more pronounce changes will be in CABG+mitral surgery subgroup with previously increasing IMR. The worst results are expected in CABG-subgroup with previously increasing IMR during exercise. There will be clarified which parameters would be more correlate with the clinic improvement (contractile reserve, B-lines, ERO etc). We expected reduced MACE till 3 year in CABG+mitral surgery subgroup with increasing IMR in comparison with CABG-subgroup with increasing IMR. Group 2, The group with massive IMR (ERO≥0.4 cm2 and RV≥60 ml) will be better according clinic, echo, stress echo results in comparison with CABG-subgroup with increasing IMR from group 1. There will be clarified which parameters would be more correlate with the clinic improvement (contractile reserve, B-lines, ERO etc). |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Ischemic Mitral Regurgitation | ||||||||||||||
Intervention ICMJE | Procedure: Mitral surgery
Guidelines approved mitral surgery
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
400 | ||||||||||||||
Original Estimated Enrollment ICMJE |
240 | ||||||||||||||
Estimated Study Completion Date ICMJE | December 31, 2027 | ||||||||||||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Russian Federation | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04023058 | ||||||||||||||
Other Study ID Numbers ICMJE | 2/2019 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Zagatina Angela, Saint Petersburg State University, Russia | ||||||||||||||
Study Sponsor ICMJE | Saint Petersburg State University, Russia | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Saint Petersburg State University, Russia | ||||||||||||||
Verification Date | September 2020 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |