Clinical trial NCT02047266: Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting
Official title: Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting (MICS CABG) Versus Off Pump (OPCABG) and on Pump Coronary Artery Bypass Grafting (ONCABG) in Patients With Multi-vessel Coronary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Keywords: MICS CABG OPCABG ONCABG CAD
Lead sponsor: Vitebsk Regional Clinical Hospital
Sponsor class: OTHER_GOV
First posted: 2014-01-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare three different revascularization strategies in patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG.

The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass grafting) has advantages in comparison with conventional off-pump (OPCABG) and on-pump coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral events (MACCE) and procedural success.

Detailed description: Prospective, single-center, randomized trial, intended to compare three different revascularization strategies in patients with multi-vessel coronary artery disease:

1. MICS CABG. Minimally invasive cardiac surgery coronary artery bypass grafting (complete multivessel minimally invasive off-pump revascularization via left minithoracotomy). (MICS CABG group, n=50).
2. OPCABG. Off-pump coronary artery bypass grafting treatment (OPCABG group, n=50).
3. ONCABG. On-pump coronary artery bypass grafting treatment (ONCABG group, n=50). The endpoints: The primary endpoints will be death, MI, stroke, or new myocardial ischemia and will be target vessel revascularization and non-target vessel revascularization at 30 days, 12 months and 3-year follow-up.

The secondary endpoints: Procedural success, Procedural and post-procedural blood loss and number of transfusions, Wound complications, Recovery time, Heart Failure (New York Heart Association (NYHA)), Life quality assessed by one of the life quality questionnaires.

Eligibility criteria: Inclusion Criteria:

* Multi-vessel coronary artery disease with ≥ 70% artery stenosis (according to QCA)
* II-IV Canadian Cardiovascular Society functional class of angina
* Patients at 1 month after acute myocardial infarction
* Ability to perform either of revascularization methods (MICS CABG, OPCABG, ONCABG)
* Patients must have signed an informed consent

Exclusion Criteria:

* Pregnancy.
* Acute coronary syndrome.
* Previous CABG.
* Severe comorbidity with high procedural risk for either of the studied strategies.
* Mental diseases which block the revascularization procedure.
* Severe peripheral artery disease.
* Other serious diseases limiting life expectancy (e.g. oncology)
* Inability for long-term follow-up.
* Participation in other clinical trials.
* Single vessel disease.
* Need for emergency revascularization (Acute MI, Acute coronary syndrome etc.)

Primary outcomes:
measure: MACCE
timeFrame: up to 3 years
Secondary outcomes:
measure: Procedural success
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Transfusion rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Recovery time
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: New York Heart Association (NYHA) class modification with respect to baseline
timeFrame: up to 3 years
measure: Wound infection
timeFrame: up to 12 months postoperatively
measure: New-onset renal failure
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Respiratory insufficiency
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Return to full physical activity postoperatively
timeFrame: up to 3 years
measure: Intensive care unit (ICU) stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
measure: Procedural and post-procedural blood loss
timeFrame: up to first twenty-four hours postoperatively
Locations:
city: Vitebsk
country: Belarus
facility: Vitebsk regional clinical hospital
state: Vitebsk region
Study officials:
affiliation: Vitebsk Regional Clinical Hospital
name: Aliaksandr A Ziankou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: