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New treatment option for Coronary Artery Disease
Official title CABG or PCI in Patients With Ischemic Cardiomyopathy
ClinicalTrials.gov ID: NCT05329285
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- Symptomatic HF defined as NYHA HF class II-IV within 1 month of enrolment
- LVEF ≤ 40% quantified by either echocardiography or gated SPECT ventriculography, or magnetic resonance (MR) or any other recognized assessment of...
- Meaningful amount of myocardium at risk because of CAD (BCIS myocardial jeopardy score ≥ 6 on a recent (\> 6 months) coronary angiogram);
- Heart team believes that a meaningful revascularization can be achieved by both PCI or CABG, with complete revascularization defined as residual...
You likely can't join if
- Previous randomization in the study
- Decompensated heart failure requiring inotropic /adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular...
- Recent (\<1 month) type 1 myocardial infarction
- Recent PCI (\<3 months)
- Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) requiring surgical repair/replacement
- Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy
See the full eligibility criteria
- Age ≥18 years.
- Symptomatic HF defined as NYHA HF class II-IV within 1 month of enrolment
- LVEF ≤ 40% quantified by either echocardiography or gated SPECT ventriculography, or magnetic resonance (MR) or any other recognized assessment of LVEF
- Meaningful amount of myocardium at risk because of CAD (BCIS myocardial jeopardy score ≥ 6 on a recent (\> 6 months) coronary angiogram);
- Heart team believes that a meaningful revascularization can be achieved by both PCI or CABG, with complete revascularization defined as residual ischemia in \<10% of the left ventricle
- Heart team agrees that guideline directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute...
- Written informed consent obtained
- Previous randomization in the study
- Decompensated heart failure requiring inotropic /adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization
- Recent (\<1 month) type 1 myocardial infarction
- Recent PCI (\<3 months)
- Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) requiring surgical repair/replacement
- Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy
- Expected survival less than 3 years due to non-cardiac illness
- Circumstances likely to lead to poor treatment compliance
- Individuals for whom record in public health databases is not accessible (non-eligibility to public health system, parallel healthcare systems
- Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.