STunning After Balloon Occlusion (STABO)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Intracoronary balloon inflation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Björn Redfors, AssocProf; Phone Number: +46 31 342 7543; Email: Bjoern.Redfors@wlab.gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Recruiting
    • Kardiologen
    • Contact: Björn S Redfors, PhD, MD; Phone Number: +46313427543; Email: Bjoern.Redfors@wlab.gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with a significant coronary artery lesion; Balloon inflation for 90s	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Björn Redfors, Sahlgrenska Universitetssjukhus

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Anticipated): July 15, 2023
• Study Completion (Anticipated): December 15, 2025

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Myocardial stunning
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: v.2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to GDPR regulation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No