Back to results

STunning After Balloon Occlusion (STABO)

Primary Purpose

Coronary Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Intracoronary balloon inflation

About this trial

This is an interventional other trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, Myocardial stunning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age >18 years.
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)
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.

Sites / Locations

KardiologenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with a significant coronary artery lesion

Arm Description

Balloon inflation for 90s

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Difference in percent Akinesia

Difference in percent Akinesia at 30 minutes compared to baseline (before balloon occlusion).

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.

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)

Percent Akinesia

Percent Akinesia in the myocardial segments

Radial myocardial Strain

Radial myocardial Strain (in percent) in the myocardial segments subtended by the target vessel measured with speckle tracking.

Global longitudinal Strain

Global longitudinal Strain (in percent) in the heart measured with speckle tracking.

Myocardial wall motion index

Left ventricular ejection fraction

Left ventricular stroke volume index

Full Information

NCT ID

NCT05023629

First Posted

July 5, 2021

Last Updated

October 12, 2022

Sponsor

Vastra Gotaland Region

1. Study Identification

Unique Protocol Identification Number

NCT05023629

Brief Title

STunning After Balloon Occlusion

Acronym

STABO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 6, 2021 (Actual)

Primary Completion Date

July 15, 2023 (Anticipated)

Study Completion Date

December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention, Myocardial stunning

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

A single-center, single-arm, prospective study

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with a significant coronary artery lesion

Arm Type

Other

Arm Description

Balloon inflation for 90s

Intervention Type

Other

Intervention Name(s)

Intracoronary balloon inflation

Intervention Description

Patients with a significant coronary artery lesion in a proximal coronary segment will undergo intracoronary balloon inflation for 90s prior to PCI.

Primary Outcome Measure Information:

Title

Precent Akinesia

Description

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).

Time Frame

30 minutes post balloon occlusion

Secondary Outcome Measure Information:

Title

Difference in percent Akinesia

Description

Difference in percent Akinesia at 30 minutes compared to baseline (before balloon occlusion).

Time Frame

30 minutes

Title

Difference in radial myocardial Strain

Description

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 Frame

30 minutes

Title

Time until recovery of radial Strain

Description

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)

Time Frame

30 minutes

Title

Percent Akinesia

Description

Percent Akinesia in the myocardial segments

Time Frame