Prospective Cohort Study on Minimal Invasive Coronary Surgery

NCT04267835 | Unknown DMC

• 1 other identifier: PKU MICS study
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

CABG technology is recognized as the preferred treatment, and its major adverse cardiac and cerebral event(MACCE) incidence and mortality are lower than percutaneous coronary intervention(PCI). However, the traditional CABG procedure requires sternal incision, large trauma and long recovery period after surgery. How to reduce trauma and treat multiple complex coronary lesions under minimally invasive conditions has become a hot spot. MIDCAB surgery can complete the coronary anastomosis only by a 6-8 cm incision in the left chest. It has been more than ten years since the first literature report in the world, however, due to the technical bottleneck, a unified and standardized surgical procedure has not yet been formed. Some centers are still in the exploratory stage, and internationally Large-scale studies of clinical outcomes (mostly less than 150 cases) have not been reported. Assessing the minimally invasive procedure's safety and effectiveness has become an urgent problem to be solved. At present, our center has completed nearly 200 cases of small incision multi-coronary coronary artery bypass graft surgery. The investigators evaluate the patency of the graft by the postoperative of angiography, the patency of grafts is more than 95%, and there is no statistical difference with conventional OPCABG. On the other hand, focus on the postoperative complications, there was no significant difference in the incidence of MACCE and revascularization between the MIDCAB group and conventional surgery during hospitalization. The investigators assume that the early results of this procedure are safe and effective. MIDCAB has a congenital advantage because of its' reduction of the trauma of the thoracotomy and the aesthetics of the incision. Therefore, if a larger sample size study and mid-term follow-up results are obtained, and the conclusion prove that the safety of the small incision surgery and the patency of the grafts are not inferior to conventional surgery. The investigators can consider that minimal invasive coronary surgery(MICS) is a technique worth trying to promote. Through this prospective cohort study, the investigators evaluated the safety of MICS through mid-term follow-up results and asses the efficiency by the results of grafts patency (angiography or CT within 30 days after surgery) and medical outcomes study-short from scores(SF-36), establish the surgical standard and perioperative management method.

Conditions

Coronary Artery Bypass, Off-Pump

Keywords

Coronary artery bypass grafting; Minimally Invasive Surgical Procedures; Off-pump CABG

Outcome Measures

Primary Outcomes (3)

• Rate of 1 years graft occlusion rate

  12 months occlusion rate of graft(Evaluate by angiography of CT angiography )

  12 months after the MIDCAB or OPCABG surgery

• 30 days PCS scores

  PCS scores calculated from the SF-36

  30days after the MIDCAB or OPCABG surgery

• 30 days mental health summary scales(MCS) of SF-36 scores

  MCS scores calculated from the SF-36

  30days after the MIDCAB or OPCABG surgery

Secondary Outcomes (5)

• Rate of 30 days graft occlusion rate

  within 30days after the MIDCAB or OPCABG surgery

• MCS scores

  7 days, 3 months, 6 months and 12 months after the MIDCAB or OPCABG surgery

• PCS scores

  7 days, 3 months, 6 months and 12 months after the MIDCAB or OPCABG surgery

• Rate of Perioperative MACCE

  Within 30 days of the MIDCAB or OPCABG surgery

• Rate of mid-term MACCE incidence

  12 months after the MIDCAB or OPCABG surgery

Other Outcomes (8)

• Number of Transfusion volume

  Within 30 days after the MIDCAB or OPCABG surgery

• mechanical ventilation time (hours)

  Within 30 days after the MIDCAB or OPCABG surgery

• Rate of wound infection

  Within 90 days of the MIDCAB or OPCABG surgery

Study Arms (2)

MICS (Minimal invasive coronary surgery)

Patients undergoing MIDCAB surgery.

Procedure: MIDCAB

OPCABG (thoracotomy off-pump CABG)

Patients undergoing thoracotomy OPCABG surgery

Procedure: thoracotomy OPCABG

Interventions

MIDCAB PROCEDURE

Surgery: MIDCAB

MICS (Minimal invasive coronary surgery)

thoracotomy OPCABG PROCEDURE

Surgery: thoracotomy OPCABG

OPCABG (thoracotomy off-pump CABG)

Eligibility Criteria

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

Study Population

Patients are planned for undergoing off-pump coronary artery bypass surgery.

You may qualify if:

• Patients are planned for undergoing off-pump coronary artery bypass surgery.

You may not qualify if:

• BMI greater than 28
• trauma, surgical or radiotherapy history of left chest
• EF less than 40%
• Simultaneous other cardiac surgery or planned cardiopulmonary bypass
• Preoperative critical situation: acute myocardial infarction, heart failure and other conditions require emergency surgery. Preoperative nitrate drugs are difficult to control angina and needs IABP implantation.
• Respiratory function: severe hypoxemia (pO2 less than 60 mmHg without Oxygen inhalation), carbon dioxide retention (pCO2 \> 50 mmHg), severe chronic obstructive pulmonary disease (FEV1/forced vital capacity less than 70% and FEV1 less than 50%)
• Aortic lesions: patients with ascending aorta calcification confirmed by preoperative CT
• Peripheral vascular lesions:By the preoperative assessment with ultrasound or CT，LIMA and left subclavian artery stenosis\>70% ,or bilateral femoral artery calcification, stenosis\>50%
• Drug therapy: Preoperative antiplatelet or anticoagulant therapy (except aspirin and clopidogrel)

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (1)

• Ding T, Gong Y, Fu Y, Cui Z, Wu S, Yang W, Yang H, Zhao H, Feng H, Zheng H, Meng L, Guo R, Han H, Ling Y. Minimally invasive coronary bypass grafting for treating multivessel coronary disease: A single-center prospective pilot study. JTCVS Open. 2025 May 4;25:96-119. doi: 10.1016/j.xjon.2025.03.030. eCollection 2025 Jun.

  PMID: 40631015 DERIVED

Study Officials

• Yunpeng Ling, Doctor

  Peking University Third Hospital

  STUDY CHAIR

• Yichen Gong, Doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yichen Gong, Doctor

CONTACT

8618611693463; 18611693463@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: February 13, 2020
• Study Start: April 4, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: November 9, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)