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

Myocardial Ischemia by 15O-H2O PET/CT in Patients With Coronary Artery Disease and Refractory Angina - Evaluation of the Coronary Sinus Reduction Stent Method

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Angina Pectoris
• Intervention / Treatment: Device: Coronary sinus reduction stent

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Øyvind Lie, MD, PhD; Phone Number: +4793429011; Email: oyvlie@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with coronary artery disease and refractory angina who are under clinical care are informed and screened for participation if consent is provided.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with refractory angina undergoing coronary sinus reduction stent implantation	Device: Coronary sinus reduction stent; Percutaneous stent implantation to reduce the dimension of the coronary sinus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial ischemia	Change in myocardial flow reserve on 15O-H2O PET/CT	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in angina burden	Seattle angina questionnaire (SAQ-7) score ranging 0 (bad) -100 (good) will be assessed at baseline and after 6 months.	6 months
Change in quality of life	Kansas City Cardiomyopathy Questionnaire (KCCQ) score ranging 0 (bad) -100 (good) will be assessed at baseline and after 6 months.	6 months
Change in exercise capacity	Maximum oxygen extraction on cardiopulmonary exercise test assessed at baseline and after 6 months.	6 months
Change in coronary microcirculation	Invasive assessment of coronary flow reserve (CFR) at baseline and at 6 months	6 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Øyvind H Lie, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Angina Pectoris
• Other Study ID Numbers: 657796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We aim to share data upon request from other academic investigators, but await EC approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No