What side effects are associated with this type of intervention?

Minimally Invasive Coronary Surgery (MICS CABG) typically results in fewer complications compared to traditional sternotomy CABG, but potential side effects include infection, bleeding, and arrhythmias. Traditional CABG can also lead to complications such as stroke, myocardial infarction, and prolonged recovery time. Common medications for CAD, such as statins, may cause muscle pain, liver damage, and increased blood sugar levels. Antiplatelet agents can increase the risk of bleeding, while beta-blockers may cause fatigue, cold extremities, and bradycardia. Lifestyle changes generally have fewer side effects but require significant patient commitment.

What prior FDA approvals exist?

The FDA has approved several treatments for Coronary Artery Disease (CAD) that aim to reduce recovery time and improve post-operative quality of life, similar to the goals of MICS CABG. These include minimally invasive surgical techniques such as percutaneous coronary intervention (PCI) with stent placement, which involves threading a catheter through a small incision to place a stent in the coronary artery. Additionally, the FDA has approved various drug-eluting stents that release medication to prevent artery re-narrowing. These advancements in minimally invasive procedures and devices have significantly improved patient outcomes by reducing the invasiveness of traditional open-heart surgeries.

What other types of research exist?

Promising novel alternatives to MICS CABG for CAD patients in 2024 include: 1) Transcatheter Aortic Valve Replacement (TAVR) for patients with concomitant aortic stenosis, which is less invasive and has shown good outcomes. 2) Percutaneous Coronary Intervention (PCI) with drug-eluting stents, which continues to evolve with improved stent designs and techniques. 3) Hybrid Coronary Revascularization (HCR), combining minimally invasive surgical grafting with PCI, offering the benefits of both approaches. 4) Robotic-assisted coronary artery bypass surgery, which enhances precision and reduces recovery time. These alternatives provide less invasive options with potential for quicker recovery and improved quality of life.

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Minimally Invasive vs. Conventional Heart Bypass for Coronary Artery Disease (MIST Trial)

N/A

Recruiting

Led By Marc Ruel, MD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Angiographically-confirmed multi-vessel coronary artery disease lesions with >=70% in at least 2 major epicardial vessels in 2 or more coronary artery territories (left anterior descending (LAD), circumflex (CX) and right coronary artery (RCA)) OR lesions >=50% in the left main (LM)

18 years of age or older

Must not have

Contraindications for conventional CABG via sternotomy

Previous cardiac surgery, mediastinal irradiation, or significant trauma to the chest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the first 2 months after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a less invasive heart surgery to traditional open-chest surgery in patients with multiple blocked heart arteries. The goal is to see if the less invasive method helps patients recover quicker and improve their quality of life. The less invasive surgery was developed to allow adequate exposure and complete treatment from a small incision without the need for a heart-lung machine.

Who is the study for?

Adults with multi-vessel coronary artery disease suitable for bypass surgery via sternotomy or a minimally-invasive approach, who can follow the study's procedures. Excluded are those under 18, previous heart surgery patients, emergency cases, and individuals with life-threatening diseases or conditions that contraindicate the surgical methods.

What is being tested?

The MIST Trial compares two types of heart bypass surgeries: MICS CABG (through a small chest incision) and conventional sternotomy CABG (through a larger chest opening). It aims to assess which method offers better quality of life and quicker recovery post-surgery using patient questionnaires over one year.

What are the potential side effects?

Potential side effects may include risks associated with any major heart surgery such as infection at the incision site, bleeding, blood clots, pneumonia, or reactions to anesthesia. The less invasive MICS procedure might reduce some risks compared to conventional CABG.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe blockages in two or more of my heart's major arteries.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have traditional open-heart surgery.

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I have had heart surgery, chest radiation, or major chest injury.

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I am having a heart surgery along with a bypass.

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I do not have severe chest deformity, serious lung or heart issues, extreme obesity, or missing femoral pulses.

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I had emergency heart bypass surgery due to unstable heart function.

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I am under 18 years old.

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I have a serious illness that may shorten my life to under 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the first 2 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the first 2 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the first 2 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of life - physical function

Secondary study objectives

Angina

Atrial fibrillation

Duration of intubation

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Minimally-invasive CABGExperimental Treatment1 Intervention

Patients in this group will undergo coronary artery bypass grafting (CABG) using a minimally-invasive approach (MICS CABG), through smaller incisions between the ribs.

Group II: CABG with sternotomyActive Control1 Intervention

Patients in this group will undergo coronary artery bypass grafting (CABG) in the usual way, through an incision in the middle of the chest, through the breastbone or sternum (conventional CABG).

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Coronary Artery Disease (CAD) is commonly treated through a combination of lifestyle changes, medications, and surgical interventions. Medications such as statins lower cholesterol levels, antiplatelet agents prevent blood clots, and beta-blockers reduce heart workload. Surgical treatments like Coronary Artery Bypass Grafting (CABG) involve creating a bypass around blocked arteries to restore blood flow to the heart. Minimally Invasive Coronary Surgery (MICS CABG), performed through a small incision over the left chest, offers a less invasive alternative to traditional sternotomy CABG. This approach reduces recovery time and improves post-operative quality of life by minimizing surgical trauma and associated complications. These treatments are crucial for CAD patients as they alleviate symptoms, improve heart function, and reduce the risk of heart attacks and other cardiovascular events.