Clinical Trials Logo

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).


Recruitment information / eligibility

Status Suspended
Enrollment 400
Est. completion date December 31, 2027
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ischemic MR, ERO=0.2 cm2 and RV=30 ml. - Indication for CABG Exclusion Criteria: - Unwillingness to give informed consent and to enter a regular follow-up program. - Contraindications for SE.

Study Design


Intervention

Procedure:
Mitral surgery
Guidelines approved mitral surgery

Locations

Country Name City State
Russian Federation St. Petersburg State University Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary myocardial infarction myocardial infarction during 3 year
Primary all-cause death all-cause death during 3 year
Primary new hospital readmission new hospitalization during 3 year from including
Primary re-operation percutaneous coronary intervention, coronary bypass surgery, heart transplant during 3 year
Primary cardiac death cardiac death during 3 year
Secondary physical capacity Change in Watts during stress test Change from Baseline of physical capacity in Watts at 12 months, at 3 years
Secondary end diastolic volume of left ventricle Change in milliliters by echocardiography Change from Baseline of end diastolic volume of left ventricle at 12 months, at 3 years
Secondary left atrium volume Change in milliliters by echocardiography Change from Baseline of left atrium volume at 12 months, at 3 years
Secondary ejection fraction at rest and during stress echo Change in percent by echocardiography at rest and at the peak of exercise during stress test Change from Baseline of ejection fraction at 12 months, at 3 years
Secondary effective regurgitant orifice Change in centimeter square of mitral effective regurgitant orifice by echocardiography Change from Baseline at 12 months, at 3 years
Secondary right ventricle size Change in centimeter of right ventricle by echocardiography Change from Baseline at 12 months, at 3 years
Secondary pulmonary artery pressure pressure Change in mm Hg of pulmonary pressure by echocardiography Change from Baseline at 12 months, at 3 years
Secondary B-lines counts of B-lines during by stress echocardiography Change from Baseline at 12 months, at 3 years
Secondary Contractile reserve Change in contractile reserve by stress echocardiography Change from Baseline at 12 months, at 3 years
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04396379 - Epicardial Mitral Touch System for Mitral Insufficiency N/A
Enrolling by invitation NCT01979965 - Effect of Ranolazine on Valvular Disease in Patients With Pacemakers Phase 4
Not yet recruiting NCT04106648 - Effect of Significant Ischemic Mitral Regurgitation on the Outcome of ST Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention
Recruiting NCT05469165 - Serotonin Receptor Blockers in Ischemic Mitral Regurgitation Phase 2