All studies
Active not recruitingNAINTERVENTIONAL

The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial

This study is looking at two ways to do heart bypass surgery for blocked arteries in your heart. One is called MICS CABG, which uses a small cut on your chest, and the other is traditional open-chest surgery, called sternotomy CABG. Doctors want to find out if the keyhole surgery helps people get back to their normal activities quicker and feel better in the months after their operation. They will compare how good patients' lives feel and how well they recover at different times after surgery, like after 1 month, 3 months, 6 months, and a year. This research could help decide which surgery is best for patients with blocked heart arteries.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
Ottawa Heart Institute Research Corporation
Enrolment target
176
Start
01 Sep 2018
Estimated completion
01 Mar 2028

What is this study about?

This study is about a common heart problem called coronary artery disease, where the blood vessels supplying your heart become narrowed or blocked. When this happens, doctors sometimes recommend a surgery called coronary artery bypass grafting (CABG). This operation helps create new routes for blood to flow around the blockages.

Traditionally, this surgery involves a larger cut down the middle of your chest. However, a newer method, called Minimally Invasive Coronary Surgery (MICS CABG), uses a much smaller cut, usually on the left side of the chest. This new approach might mean a quicker recovery and getting back to your normal life sooner, but doctors want to be sure.

That's why this study, called the MIST Trial, is being done. Researchers want to properly compare these two types of surgery. They will carefully look at how patients feel and recover after each type of surgery, using questionnaires about their quality of life. The goal is to see if MICS CABG truly offers better recovery and quality of life in the first year after surgery compared to the traditional method, and this could help surgeons decide the best way to operate in the future.

Key takeaways

  • Compares traditional open-chest heart bypass with a keyhole method.
  • Aims to find out if keyhole surgery helps patients recover faster and feel better.
  • Participation involves being randomly assigned to one of the two surgery types.
  • You'll complete quality of life questionnaires over 12 months.
  • Helps doctors understand the best surgical options for blocked heart arteries.

Who may be eligible?

To join this study, you must be 18 years old or older and have blockages in several of the important arteries around your heart. Your doctor will need to agree that both the traditional and the keyhole surgery methods are suitable options for you.

There are also some reasons why you wouldn't be able to join. For example, if you've already had heart surgery or certain chest treatments, or if you have other serious health problems that might shorten your life significantly. Also, if you need other heart procedures at the same time as your bypass surgery, or if you can't come to all the follow-up appointments, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 or older?
  2. Do you have blockages in several major heart arteries?
  3. Has your doctor said both traditional and keyhole bypass surgery might be suitable for you?
  4. Are you able to attend follow-up appointments for a year after surgery?
  5. Have you not had previous heart surgery or certain chest treatments?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to have either the traditional bypass surgery (sternotomy CABG) or the keyhole bypass surgery (MICS CABG). This is like flipping a coin, so neither you nor your doctor can choose which type of surgery you will have for the study. After your surgery, you will be asked to complete some questionnaires about your health and quality of life. These will be done at 1 month, 3 months, 6 months, and 12 months after your operation. This helps the study team understand how you are recovering and feeling. You won't be given any new or experimental medications as part of this study; it's about comparing surgical techniques. The total duration of your active participation, including follow-up, will be 12 months.

Potential risks and benefits

Participating in this study might offer the benefit of receiving potentially quicker recovery with the MICS CABG, though this is what the study aims to confirm. Regardless of which surgery you receive, you'll be contributing to important medical research that could help future patients with similar heart conditions. However, both surgeries carry their own known risks, which your medical team will discuss with you. You have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (13)

  • University of Pittsburgh Medical Center
    Verified postcode
    Pittsburgh, United States
  • Gundersen Lutheran Medical Center
    Verified postcode
    La Crosse, United States
  • Universitaire Ziekenhuizen Leuven
    Verified postcode
    Leuven, Belgium
  • Division of Cardiac Surgery, University of Ottawa Heart Institute
    Verified postcode
    Ottawa, Canada
  • University Health Network
    Verified postcode
    Toronto, Canada
  • Jilin Heart Hospital
    Verified postcode
    Jilin City, China
  • Leipzig Heart Institute GmbH
    Verified postcode
    Leipzig, Germany
  • Robert-Bosch-Hospital
    Verified postcode
    Stuttgart, Germany
  • Apollo Hospital, Bangalore
    Verified postcode
    Bangalore, India
  • Manipal Hospitals
    Verified postcode
    New Delhi, India
  • Tokyo Bay Urayasu Ichikawa Medical Center
    Verified postcode
    Urayasu, Japan
  • National University Hospital (NUH) - Singapore
    Verified postcode
    Singapore, Singapore

Common questions

What is the main purpose of this study?

To compare two types of heart bypass surgery (traditional vs. keyhole) to see which leads to a better recovery and quality of life.

What does 'randomly assigned' mean?

It means you will be chosen by chance, like a lottery, to receive either one type of surgery or the other for the study.

Will I get special medicine in this study?

No, this study is about comparing surgical methods, not new medicines. You will receive standard post-operative care.

How long will I be involved in the study?

You will be followed up for 12 months after your surgery, with questionnaires at specific times during that year.

Can I change my mind and leave the study?

Yes, you can leave the study at any time, and it won't affect your ongoing medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.