STunning After Balloon Occlusion
- Conditions
- Coronary Artery Disease
- Interventions
- Other: Intracoronary balloon inflation
- Registration Number
- NCT05023629
- Lead Sponsor
- Vastra Gotaland Region
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
-
Age >18 years.
-
Stable CAD with indication for PCI of a lesion in either of the following coronary segments:
- 6 or 7 (proximal or mid left anterior descending coronary artery)
- 11 (Proximal left circumflex coronary artery)
- 1 or 2 (proximal right coronary artery)
-
Normal cardiac function in the myocardial segments subtended by the target vessel, as assessed by echocardiography at the time of coronary angiography.
-
Written informed consent obtained.
- Pre-existing heart failure
- Known pre-existing irreversible regional or global wall motion abnormalities affecting the myocardial segments subtended by the target vessel.
- Severe valvulopathy
- Thrombolysis In Myocardial Infarction (TIMI) flow <3 in the target vessel.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with a significant coronary artery lesion Intracoronary balloon inflation Balloon inflation for 90s
- Primary Outcome Measures
Name Time Method Precent Akinesia 30 minutes post balloon occlusion Time until recovery of percent akinesia (percent Akinesia; defined as more than 80 percent recovery compared to percent Akinesia at 30 minutes post balloon occlusion).
- Secondary Outcome Measures
Name Time Method Difference in radial myocardial Strain 30 minutes Difference in radial myocardial Strain (in percent) in the myocardial segments subtended by the target vessel at 30 minutes compared to baseline measured with speckle tracking.
Time until recovery of radial Strain 30 minutes Time until recovery of radial Strain in the myocardial segments subtended by the target vessel (defined more than 80 percent recovery compared to 30 minutes post balloon occlusion)
Radial myocardial Strain 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours Radial myocardial Strain (in percent) in the myocardial segments subtended by the target vessel measured with speckle tracking.
Global longitudinal Strain 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours Global longitudinal Strain (in percent) in the heart measured with speckle tracking.
Percent Akinesia 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours Percent Akinesia in the myocardial segments
Myocardial wall motion index 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours Myocardial wall motion index
Left ventricular stroke volume index 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours Left ventricular stroke volume index
Difference in percent Akinesia 30 minutes Difference in percent Akinesia at 30 minutes compared to baseline (before balloon occlusion).
Left ventricular ejection fraction 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours Left ventricular ejection fraction
Trial Locations
- Locations (1)
Kardiologen
🇸🇪Gothenburg, Sweden