Actively Recruiting
CABG or PCI in Patients With Ischemic Cardiomyopathy
Led by Vastra Gotaland Region · Updated on 2024-06-24
470
Participants Needed
1
Research Sites
1580 weeks
Total Duration
On this page
Sponsors
V
Vastra Gotaland Region
Lead Sponsor
R
Region Örebro County
Collaborating Sponsor
AI-Summary
What this Trial Is About
The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) \<40%) and multi-vessel coronary artery disease.
CONDITIONS
Official Title
CABG or PCI in Patients With Ischemic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Symptomatic heart failure classified as NYHA class II-IV within 1 month before enrollment
- Left ventricular ejection fraction 40% or less measured by echocardiography, gated SPECT ventriculography, magnetic resonance, or other accepted methods
- Significant myocardium at risk due to coronary artery disease with a BCIS myocardial jeopardy score of 6 or higher on a recent coronary angiogram
- Heart team agrees that both PCI and CABG can achieve meaningful revascularization with less than 10% residual ischemia of the left ventricle
- Guideline directed medical therapy for heart failure has been started for at least 1 month before enrollment or initiated in hospital before randomization if newly diagnosed
- Written informed consent obtained
You will not qualify if you...
- Previous participation in this study
- Decompensated heart failure requiring inotropic or adrenergic support, ventilation, intra-aortic balloon pump, or ventricular assist device within 48 hours prior to randomization
- Type 1 myocardial infarction within the last 1 month
- Percutaneous coronary intervention within the last 3 months
- Valvular heart disease or other cardiac conditions requiring surgical repair or replacement
- High risk of bleeding or need to avoid long-term dual antiplatelet therapy
- Expected survival less than 3 years due to non-cardiac illness
- Likely poor treatment compliance
- Lack of accessible public health records or participation in parallel healthcare systems
- Pregnancy or women of childbearing potential not sterilized or not using accepted contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kardiologen
Gothenburg, Sweden, 41345
Actively Recruiting
Research Team
B
Björn Redfors, MD, PhD
CONTACT
E
Elmir Omerovic, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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