Myocardial Ischemia After Coronary Sinus Reduction Stent Implantation

Angina Pectoris Clinical Trial

— MICS-Reduce  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06033495
• Other study ID #: 657796
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2023
• Source: Oslo University Hospital
• Contact: Øyvind Lie, MD, PhD
• Phone: +4793429011
• Email: oyvlie[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 1, 2025
• Est. primary completion date: November 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Coronary sinus reduction stent
Percutaneous stent implantation to reduce the dimension of the coronary sinus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial ischemia	Change in myocardial flow reserve on 15O-H2O PET/CT	6 months
Secondary	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
Secondary	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
Secondary	Change in exercise capacity	Maximum oxygen extraction on cardiopulmonary exercise test assessed at baseline and after 6 months.	6 months
Secondary	Change in coronary microcirculation	Invasive assessment of coronary flow reserve (CFR) at baseline and at 6 months	6 months