STunning After Balloon Occlusion

Study Overview
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Brief Summary
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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
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Primary objectives: 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: 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. To establish a clinical model for studying myocardial stunning.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Intracoronary balloon inflation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: A single-center, single-arm, prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with a significant coronary artery lesion<br>Balloon inflation for 90s | Other: Intracoronary balloon inflation<br>* Patients with a significant coronary artery lesion in a proximal coronary segment will undergo intracoronary balloon inflation for 90s prior to PCI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precent Akinesia | 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). | 30 minutes post balloon occlusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in percent Akinesia | Difference in percent Akinesia at 30 minutes compared to baseline (before balloon occlusion). | 30 minutes | 
| Difference in radial myocardial Strain | 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. | 30 minutes | 
| Time until recovery of radial Strain | 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) | 30 minutes | 
| Percent Akinesia | Percent Akinesia in the myocardial segments | 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours | 
| Radial myocardial Strain | Radial myocardial Strain (in percent) in the myocardial segments subtended by the target vessel measured with speckle tracking. | 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours | 
| Global longitudinal Strain | Global longitudinal Strain (in percent) in the heart measured with speckle tracking. | 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours | 
| Myocardial wall motion index | Myocardial wall motion index | 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours | 
| Left ventricular ejection fraction | Left ventricular ejection fraction | 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours | 
| Left ventricular stroke volume index | Left ventricular stroke volume index | 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention, Myocardial stunning