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Minimally Invasive Cardiac SurgeryNCT05104320

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

A study testing MICS-CABG and sternotomy CABG in people with Minimally Invasive Cardiac Surgery, run by Peking University Third Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 85 years
Conditions the study is for
Minimally Invasive Cardiac Surgery
What is being tested?
MICS-CABG and sternotomy CABG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
No sites listed yet
Study dates
31 Oct 2021to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria:(A patient will be included in the study when the following criteria and requirements are met)

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.

Exclusion Criteria:(A patient will be excluded from the study if they meet any of the following criteria)

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.

Trial locations and contacts

No sites are listed yet.

Yichen Gong, Doctor contact

8618611693463

18611693463@126.com

About this study

Official title: 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

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.

Being tested
MICS-CABG, sternotomy CABG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MICS-CABGProcedure or surgery

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

  • sternotomy CABGProcedure or surgery

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

Study groups in NCT05104320
Study groupRoleWhat they receive
MICS-CABGExperimentalPatients undergoing MICS-CABG.
Receives: Procedure: MICS-CABG
sternotomy CABGActive comparatorPatients undergoing thoracotomy OPCABG.
Receives: Procedure: sternotomy CABG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days after surgery

  2. 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

    Measured: within 14 days after surgery

Secondary outcomes (11)

  1. SF-36 PCS scores

    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.

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

  2. SF-36 MCS scores

    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.

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

  3. Patency rate of the different material 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

    Measured: 14 days and 1 year after surgery

  4. Length of incubation

    the time of assisted respiratory ventilation after surgery

    Measured: within 7 days after surgery

  5. Hospitalization cost

    total hospitalization cost of each patient

    Measured: within 7 days after surgery

  6. Length of postoperative hospitalization time

    total postoperative hospitalization time of the patients

    Measured: within 7 days after surgery

  7. Bypass surgical variation index

    The actual graft number is compared with the preoperative strategy. If the actual number of grafts is less than that in the preoperative plan, the results will be recorded.

    Measured: within 7 days after surgery

  8. Intrahospital RBC transfusion volume

    the amount of red blood cells (U) to be transfused during hospitalization. Indications for blood transfusion include hemoglobin less than 90 g/L, severe intraoperative or postoperative active bleeding, or other blood transfusion considered necessary by the surgeons.

    Measured: within 7 days after surgery

  9. Wound infection rate

    wound dehiscence, effusion and secondary debridement and suture

    Measured: within 3 months after surgery

  10. Number of Participants with re-exploration for bleeding or other causes (not including wound-related causes)

    the requirement to return to the operating room for reopening of sternotomy or MICS CABG incision for any reason, such as bleeding, postoperative acute myocardial ischemia and unexplained circulatory instability. Debridement for DSWI or infection of anterior-lateral wounds will be excluded.

    Measured: within 1 year after surgery

  11. Major adverse cardiac and cerebrovascular events (MACCEs)

    Composite endpoint of all-cause death, nonfatal myocardial infarction, stroke, and target vessel ischemia-driven repeated revascularization (TVR).

    Measured: 1, 6, 12, 24, 36, and 60 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2021
  2. Study start31 Oct 2021 (estimated)
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
248 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05104320
Sponsor's protocol ID
PKU MICS-CABG PRPP Trial
Status last verified
Sep 2021
First submitted
9 Oct 2021
Last updated
2 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing MICS-CABG and sternotomy CABG in people with Minimally Invasive Cardiac Surgery, run by Peking University Third Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yichen Gong, Doctor (8618611693463, 18611693463@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SF-36 PCS score (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05104320.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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