CABG or PCI in Patients With Ischemic Cardiomyopathy - A Randomized Registry Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible, in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization

• Written informed consent obtained

Locations
Other Locations
Sweden
Kardiologen
RECRUITING
Gothenburg
Contact Information
Primary
Björn Redfors, MD, PhD
Bjoern.Redfors@wlab.gu.se
+46313427543
Backup
Elmir Omerovic, MD, PhD
elmir@wlab.gu.se
+46 31 3421000
Time Frame
Start Date: 2022-09-14
Estimated Completion Date: 2052-12-31
Participants
Target number of participants: 470
Treatments
Experimental: Percutaneous Coronary Intervention (PCI)
Patients will be revascularized by PCI
No_intervention: Coronary artery bypass grafting (CABG)
Patients will be revascularized by CABG
Sponsors
Collaborators: University Hospital, Umeå, Region Örebro County, Karolinska University Hospital
Leads: Vastra Gotaland Region

This content was sourced from clinicaltrials.gov