Clinical Trial Details
— Status: Suspended
Administrative data
NCT number |
NCT04023058 |
Other study ID # |
2/2019 |
Secondary ID |
|
Status |
Suspended |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2020 |
Est. completion date |
December 31, 2027 |
Study information
Verified date |
October 2022 |
Source |
Saint Petersburg State University, Russia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Comparison patients with CABG alone vs. CABG+mitral surgery with non-massive ischaemic mitral
regurgitation (IMR) depending on stress echo data.
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:
1. Age > 18 years
2. IMR, ERO≥0.2 cm2 and RV≥30 ml.
3. Indication for CABG
Exclusion criteria for all projects are:
1. Unwillingness to give informed consent and to enter a regular follow-up program.
2. Contraindications for stress echo.
Methods and design:
1. In a prospective multicenter international randomized study, we will recruit patients
whom CABG is planned.
2. Conventional transthoracic echo. Patients will include into two groups:
Group 1 - "Non-massive IMR" - ERO-0.2-0.39 cm2, and RV-30-59ml. Group 2 - "Massive IMR"
- ERO≥0.4 cm2 and RV≥60 ml.
3. Randomization of Group 1 (surgery/non-surgery).
4. Exercise stress echocardiography of all the patients (Group 1 and Group 2). regional
wall motion abnormality (RWMA), ejection fraction (EF), end diastolic volume (EDV), end
systolic volume (ESV), contractile reserve, B-lines, ERO, RV, PA pressure at rest and
during stress.
5. 1-year clinical outcomes
6. 1-year transthoracic echo data.
7. 1-year stress echocardiography data.
8. 3-year clinical outcomes
9. 3-year transthoracic echo data.
10. 3-year stress echocardiography data. Primary end-points: death, myocardial infarction,
new hospital readmission, heart transplant, ventricular assist device implantation,
aborted sudden death, pulmonary oedema (MACE).
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).