Myocardial Ischemia After Coronary Sinus Reduction Stent Implantation

NCT06033495 | Unknown FDA Device

• 1 other identifier: 657796
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Myocardial ischemia

  Change in myocardial flow reserve on 15O-H2O PET/CT

  6 months

Secondary Outcomes (4)

• Change in angina burden

  6 months

• Change in quality of life

  6 months

• Change in exercise capacity

  6 months

• Change in coronary microcirculation

  6 months

Study Arms (1)

Patients with refractory angina undergoing coronary sinus reduction stent implantation

Device: Coronary sinus reduction stent

Interventions

Coronary sinus reduction stent DEVICE

Percutaneous stent implantation to reduce the dimension of the coronary sinus

Patients with refractory angina undergoing coronary sinus reduction stent implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Øyvind H Lie

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Øyvind Lie, MD, PhD

CONTACT

+4793429011; oyvlie@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: December 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: June 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09