The Quality of Life and Patency Rate After Minimally Invasive Cardiac Surgery

NCT05104320 | Unknown DMC

• 1 other identifier: PKU MICS-CABG PRPP Trial
• Study Type: interventional
• Target: 248
• Locations: 0 countries
• Sites: N/A

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 after surgery and the overall patency rate of the grafts within 14 days 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

Minimally Invasive Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• SF-36 PCS score

  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 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

Secondary Outcomes (11)

• SF-36 PCS scores

  7 days, 3 months, 6 months and 1 year after surgery

• SF-36 MCS scores

  7 days, 3 months, 6 months and 1 year after surgery

• Patency rate of the different material grafts

  14 days and 1 year after surgery

• Length of incubation

  within 7 days after surgery

• Hospitalization cost

  within 7 days after surgery

Study Arms (2)

MICS-CABG

EXPERIMENTAL

Patients undergoing MICS-CABG.

Procedure: MICS-CABG

sternotomy CABG

ACTIVE COMPARATOR

Patients undergoing thoracotomy OPCABG.

Procedure: sternotomy CABG

Interventions

MICS-CABG PROCEDURE

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

MICS-CABG

sternotomy CABG PROCEDURE

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

sternotomy 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 \>75%) 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:

• ① Unstable preoperative hemodynamic status (vasoactive drugs such as dopamine, epinephrine or norepinephrine to maintain blood pressure, or an intra-aortic balloon pump \[IABP\] is implanted preoperatively) or requiring emergency surgery. ② Severe emphysema, hypoxemia \[postbronchodilator 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. ③ Old extensive myocardial infarction without a 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). ④ Severe pleural adhesion, chest deformity, or previous thoracic radiotherapy. ⑤Previous thoracotomy surgery. ⑥ Simultaneous valve or other cardiac surgery. ⑦Planned cardiopulmonary bypass surgery. ⑧Poor condition of the distal coronary artery (diffuse stenosis, chronic total obstructive lesion with severe calcification or inability to match the graft due to a small diameter (\<1.0 mm). ⑨Intolerance to surgery in combination with the following complications: Terminal cancer, uncontrolled infection, bleeding, severe brain injury, infarction or bleeding, multiple organ failure and other major organ dysfunction such as severe liver dysfunction or severe congestive heart failure.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Officials

• Yunpeng Ling

  Peking University Third Hospital

  STUDY CHAIR

• Yichen Gong

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yichen Gong, Doctor

CONTACT

8618611693463; 18611693463@126.com

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: October 9, 2021
• First Posted: November 2, 2021
• Study Start: October 31, 2021
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 2, 2021

Record last verified: 2021-09