NCT05023629

STunning After Balloon Occlusion

STunning After Balloon Occlusion, A Single-center, Single-arm, Prospective Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to examine in-depth cardiac function and morphology after short-term coronary occlusion by balloon inflation in patients with stable coronary artery disease (CAD) who undergo percutaneous coronary intervention (PCI).

Detailed description

Primary objectives: 1. To determine the time-course for the resolution of regional myocardial function after short-term coronary artery occlusion in patients with stable CAD who undergo PCI. Secondary objectives: 2. To confirm by cardiac magnetic resonance imaging that no myocardial injury occurs after short-term coronary occlusion in patients who undergo PCI due to stable CAD. 3. To establish a clinical model for studying myocardial stunning.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	Intracoronary balloon inflation	Patients with a significant coronary artery lesion in a proximal coronary segment will undergo intracoronary balloon inflation for 90s prior to PCI.

Timeline

• Start date: 2021-09-06
• Primary completion: 2023-07-15
• Completion: 2025-12-15
• First posted: 2021-08-26
• Last updated: 2022-10-13

Locations

1 site across 1 country: Sweden