NCT05104320

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

A Partially Randomized Patient Preference Trial to Assess the Quality of Life and Patency Rate After Minimally Invasive Cardiac Surgery-Coronary Artery Bypass Grafting: the MICS-CABG PRPP Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	MICS-CABG	Off-pump multi-vessel coronary artery bypass grafting via left thoracotomy under minimally invasive conditions.
PROCEDURE	sternotomy CABG	Off-pump multi-vessel coronary artery bypass grafting with conventional thoracotomy.

Timeline

• Start date: 2021-10-31
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2021-11-02
• Last updated: 2021-11-02