Coronary Artery Disease
Conditions
Keywords
Percutaneous Coronary Intervention, Myocardial stunning
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.
Interventions
OTHERIntracoronary balloon inflation
Patients with a significant coronary artery lesion in a proximal coronary segment will undergo intracoronary balloon inflation for 90s prior to PCI.
Sponsors
Vastra Gotaland Region
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A single-center, single-arm, prospective study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years. 2. Stable CAD with indication for PCI of a lesion in either of the following coronary segments: 1. 6 or 7 (proximal or mid left anterior descending coronary artery) 2. 11 (Proximal left circumflex coronary artery) 3. 1 or 2 (proximal right coronary artery) 3. Normal cardiac function in the myocardial segments subtended by the target vessel, as assessed by echocardiography at the time of coronary angiography. 4. Written informed consent obtained.
Exclusion criteria
1. Pre-existing heart failure 2. Known pre-existing irreversible regional or global wall motion abnormalities affecting the myocardial segments subtended by the target vessel. 3. Severe valvulopathy 4. Thrombolysis In Myocardial Infarction (TIMI) flow \<3 in the target vessel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Difference in percent Akinesia | 30 minutes | Difference in percent Akinesia at 30 minutes compared to baseline (before balloon occlusion). |
| 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) |
| Percent Akinesia | 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours | Percent Akinesia in the myocardial segments |
| 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. |
| 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 ejection fraction | 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours | Left ventricular ejection fraction |
| 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 |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORBjörn Redfors
Sahlgrenska Universitetssjukhus
Outcome results
None listed