MInithoraCotomy vs Sternotomy for Multivessel Coronary Artery Bypass Grafting: A Partially Randomized Patient Preference Trial Assessing Quality of Life and Patency Outcomes

NCT04795193 | Enrolling By Invitation DMC

• 1 other identifier: MICS-CABG PRPP Trial
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will address essential questions of the efficacy and safety of MICS-CABG in addition to the quality of life and patency rate of the grafts. The study will also address the impact of patients' preferences on external validity and internal validity. In this study, patients with a preference will be allocated to treatment strategies accordingly, whereas only those patients without a distinct preference will be randomized. The randomized trial is a 248-patient controlled, randomized, investigator-blinded trial. It is designed to compare whether treatment with MICS-CABG is beneficial in comparison to CABG. This study is aimed to establish the superiority hypothesis for the physical component summary (PCS) accompanied by the noninferiority hypothesis for overall graft patency. Patients with no treatment preference will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoints are the PCS score at 30 days (1 month) after surgery and the overall patency rate of the grafts within 14 days ( before discharge) after surgery. Secondary outcome measures include the PCS score and patency rate at different time points. Safety endpoints include major adverse cardiac and cerebrovascular events, complications, bleeding, wound infection, death, etc.

Conditions

Coronary Artery Bypass, Off-Pump; Minimally Invasive Cardiac Surgery

Keywords

Coronary Artery Bypass, Off-Pump; Minimally Invasive Surgical Procedures; Coronary Artery Bypass

Outcome Measures

Primary Outcomes (2)

• SF-36 PCS score (Physical component summary of medical outcomes study-short form 36-item scores) at 30 days (1month) after surgery

  The SF-36 is a concise health test that features Physical Functioning (PF), Roe-Physical (RP), Bodily Pain, General Health (GH), Vitality (VT), Social Functioning (SF), Roe-Emotional (Emotional) and Mental Health (MH) functioning and comprehensively summarizes the quality of life of the respondents across 8 aspects. The PCS and mental component summary (MCS) can be calculated from the eight abovementioned indicators with different weights. The PCS and the MCS each range from 0 to 50, with a lower score indicating worse quality of life (QoL) and a higher score indicating better QoL.

  30 days (1 month) after surgery

• Overall patency rate of the grafts

  the patency rates of the LIMA, RIMA, saphenous vein graft (SVG) and radial artery (RA) will be evaluated by the Fitzgibbon A+B grade

  within 14 days after surgery (before discharge)

Secondary Outcomes (28)

• Perioperative transfusion volume

  Intraoperative and 14 days after surgery

• Incidence of cardiopulmonary bypass conversion

  14 days after surgery

• Percentage of intra-aortic balloon pump (IABP) and extracorporeal membrane oxygenation (ECMO) usage

  14 days after surgery

• Incidence of secondary surgery

  14 days after surgery

• Incidence of adverse events of wound healing

  14 days, 1 month, 3 months, 6 months and 12 months after surgery

Study Arms (2)

MICS-CABG (minithoractomy CABG)

EXPERIMENTAL

Patients undergoing MICS-CABG(minithoractomy CABG)

Procedure: Minimal invasive coronary surgery

CABG (sterotomy CABG)

ACTIVE COMPARATOR

Patients undergoing CABG (sterotomy CABG)

Procedure: Off-pump coronary artery bypass surgery

Interventions

Minimal invasive coronary surgery PROCEDURE

Off-pump multi-vessel coronary artery bypass grafting via left thoracotomy under minimally invasive conditions.

MICS-CABG (minithoractomy CABG)

Off-pump coronary artery bypass surgery PROCEDURE

Off-pump multi-vessel coronary artery bypass grafting with conventional thoracotomy.

CABG (sterotomy CABG)

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ① Patient age of ≥25 years but ≤85 years, and patients with CAD who require multivessel coronary bypass surgery. ② Angina that affects daily life and work and is uncontrollable with conservative treatment. ③ Significant stenosis in the left main (LM) coronary artery, left anterior descending (LAD) branch or left circumflex (LCX) branch \>70%. ④ Severe stenosis (stenosis degree \>70%) of three main branches of the coronary artery (anterior descending branch, circumflex branch, right coronary artery) with the need to undergo off-pump coronary artery bypass surgery.

You may not qualify if:

• Unstable preoperative hemodynamic status requiring emergency surgery
• Severe emphysema, hypoxemia \[post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC)\<70% and FEV1%predicted\<50% or partial pressure of oxygen (pO2)\<60 mmHg or partial pressure of carbon dioxide (pCO2)\>40 mmHg without oxygen therapy\]
• Old large area myocardial infarction, no viable myocardium based on isotope and echocardiography examination, significant cardiac enlargement, cardiothoracic ratio\>0.75, EF\<30%, left ventricular diastolic diameter (LVDd)\>60 mm, left ventricular aneurysm or severe arrhythmia, prone to experience unstable preoperative hemodynamic status during surgery
• Severe pleural adhesion, chest deformity, or previous thoracic radiotherapy
• Previous open heart surgery
• Simultaneous valve or other cardiac surgery
• Planned cardiopulmonary bypass surgery
• Poor condition of myocardial infarction (MI), extensive lesion, distal or entire diffuse stenosis, or inability to match lumen due to small diameter (\<1.0 mm) or severe calcification
• Others: Terminal cancer, uncontrolled infection, bleeding, progressive degenerative systemic disease, severe brain injury, multiple organ failure and other major organ dysfunction such as severe liver dysfunction, severe heart failure or cardiogenic shock, intolerance to surgery, and other contraindications of CABG

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Officials

• Yunpeng Ling, Doctor

  Peking University Third Hospital

  STUDY CHAIR

• Yichen Gong, Doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 12, 2021
• Study Start: April 15, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: From 6 months to 3 years following the article publication of summary data.
• Access Criteria: Researches should send a proposal to yunpengling@163.com or 18611693463@126.com. If the proposal is methodologically sound, feasible and approved by the principal investigator, data requestor could gain access after signing a data access agreement.

Locations

CN (1)