STunning After Balloon Occlusion

Coronary Artery Disease Clinical Trial

— STABO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023629
• Other study ID #: v.2.0
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: December 15, 2025

Study information

• Verified date: October 2022
• Source: Vastra Gotaland Region
• Contact: Björn Redfors, AssocProf
• Phone: +46 31 342 7543
• Email: Bjoern.Redfors[@]wlab.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 15, 2025
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.

Locations

Country	Name	City	State
Sweden	Kardiologen	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in percent Akinesia	Difference in percent Akinesia at 30 minutes compared to baseline (before balloon occlusion).	30 minutes
Secondary	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
Secondary	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
Secondary	Percent Akinesia	Percent Akinesia in the myocardial segments	1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Secondary	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
Secondary	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
Secondary	Myocardial wall motion index	Myocardial wall motion index	1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Secondary	Left ventricular ejection fraction	Left ventricular ejection fraction	1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Secondary	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