Myocardial Ischemia After Coronary Sinus Reduction Stent Implantation (MICS-Reduce)

University of Oslo (UIO)

Status: Not yet enrolling

Conditions: Angina Pectoris

Treatments: Device: Coronary sinus reduction stent

Study type: Observational

Funder types: Other

Identifiers

NCT06033495

657796

Details and patient eligibility

About

Chronic angina pectoris refractory to medical and revascularization therapies is a disabling medical condition and a major public health problem. Patients with refractory angina have limited treatment options. One proposed therapy modality is transcatheter implantation of a reduction stent in the coronary sinus. Coronary sinus reduction stents have been shown to reduce angina burden considerably and to improve quality of life. The reduction stent is assumed to increase myocardial perfusion and reduce myocardial ischemia, but the mechanism of action is poorly understood.

The aim of this project is to assess the myocardial ischemia burden in patients with refractory angina who are undergoing a transcatheter coronary sinus reducer procedure. This is a clinical non-randomized self-controlled cohort study with blinded outcome adjudication for changes in myocardial perfusion. Patients with refractory angina will be systematically examined before implantation of the coronary sinus reduction stent and after 6 months. The primary outcome, changes in myocardial perfusion on the gold standard 15O-H2O PET/CT will be evaluated on blinded perfusion scans where the stent is invisible. To provide context to the findings, we will also evaluate whether changes in myocardial ischemia are associated with less angina and better cardiac function parameters. Effects of stent implantation on angina symptoms and quality of life could be affected by a placebo effect.

Treatment options for patients with refractory angina is needed, and results from the present study will explore if coronary sinus reduction stents are improving myocardial ischemia in this patient group. Signs of improved objective perfusion will inspire confidence in the method.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Coronary artery disease and refractory angina
• Clinical indication for coronary sinus reduction stent implantation
• Written informed consent
• Anticipated compliance with protocol

Exclusion criteria

• Ineligibility for coronary sinus reduction stent implantation
• Lack of informed consent
• Not expected to comply with protocol

Trial design

15 participants in 1 patient group

Patients with refractory angina undergoing coronary sinus reduction stent implantation

Treatment:

Device: Coronary sinus reduction stent