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Procedure
Heart Surgery for Coronary Artery Disease
N/A
Recruiting
Led By Stephen Fremes, MD,MSc,FRCSC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography, and/or fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. For LM disease, significant coronary stenosis is defined as >50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) ≤6.0 mm2 (<4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements
Age >18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up reported at 1 and 5 years and as a cumulative incidence.
Awards & highlights
Study Summary
This trial is testing whether CABG is better than PCI for reducing death, stroke, heart attack, and heart failure readmission in patients with ischemic cardiomyopathy and coronary artery disease.
Who is the study for?
This trial is for adults over 18 with ischemic cardiomyopathy, specifically those with significant blockages in multiple heart arteries and reduced heart pump function. Participants must have been on guideline-directed medical therapy for at least a month and be deemed suitable for non-emergency artery-opening procedures by their Heart Team.Check my eligibility
What is being tested?
The STICH3C trial compares two types of artery-opening procedures: PCI (using catheters to place stents) versus CABG (open-heart surgery to bypass blocked vessels), in patients with weak heart muscles due to blocked arteries. The goal is to see which method better reduces the risk of death, stroke, repeat procedures, or hospital readmission over five years.See study design
What are the potential side effects?
Risks include bleeding, infection, reactions from anesthesia during surgery for CABG; while PCI may cause blood vessel damage or kidney problems related to contrast dye used during the procedure. Both can lead to irregular heartbeats or future blockages.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe blockage in multiple heart arteries.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ reported at 1 and 5 years and as a cumulative incidence.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~reported at 1 and 5 years and as a cumulative incidence.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission.
Secondary outcome measures
Composite of death or cardiac hospitalization
Composite of death/stroke/spontaneous MI
Composite of death/stroke/spontaneous MI/RR
+10 moreOther outcome measures
Composite of severe stroke/ventilator dependance/new onset or worsening heart failure/ nursing home admission/ or new onset dialysis
Composite of stroke, nursing home admission and 3 or more non-elective admissions per 12 months
Cost-effectiveness
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Revascularization by PCIExperimental Treatment1 Intervention
Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter >2.0 mm for PCI. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon.
Group II: Revascularization by CABGExperimental Treatment1 Intervention
Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter >1.5 mm for CABG. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
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1,550,554 Total Patients Enrolled
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Weill Medical College of Cornell UniversityOTHER
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222,861 Patients Enrolled for Heart Failure
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,452,813 Total Patients Enrolled
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2,877,681 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe blockage in multiple heart arteries.I am not planning any major surgeries except for LAAO or AF ablation.I have not had a heart stent procedure in the last year.I cannot take certain blood thinners due to a high risk of bleeding.I do not have severe organ failure or conditions reducing my life expectancy to under 5 years.I had a major heart attack in the last 4 weeks.You may not be able to follow the treatment plan consistently.I am older than 18 years.My heart team agrees I've been on heart medication for at least a month.You are not a candidate for either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) according to the Heart Team.My heart's pumping ability is 40% or less, confirmed by a heart scan in the last 2 months.I have been diagnosed with Takotsubo Cardiomyopathy.I have not needed advanced heart failure support like special pumps or breathing help in the last 2 days.I have a severe heart valve issue or similar condition needing surgery.I have had heart surgery before.
Research Study Groups:
This trial has the following groups:- Group 1: Revascularization by CABG
- Group 2: Revascularization by PCI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are joining the research project?
"Yes, clinicaltrials.gov confirms that this medical trial is recruiting patients and was posted on May 1st 2023 with the most recent update occuring in 19th of same month. The study requires 754 participants from a single research site."
Answered by AI
Are there still opportunities for prospective participants to enroll in this research endeavor?
"Affirmative, the data on clinicaltrials.gov reveals that this medical study is actively enrolling participants. The trial was initially posted on May 1st 2023 and has been updated most recently on May 19th 2023. This project needs a total of 754 individuals to be recruited from one site."
Answered by AI
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