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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with a significant coronary artery lesion | Other | Balloon inflation for 90s |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracoronary balloon inflation | Other | Patients with a significant coronary artery lesion in a proximal coronary segment will undergo intracoronary balloon inflation for 90s prior to PCI. |
| 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 |
| 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. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Björn Redfors | Sahlgrenska Universitetssjukhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kardiologen | Gothenburg | 41345 | Sweden |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017682 | Myocardial Stunning |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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A single-center, single-arm, prospective study
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| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |