STunning After Balloon Occlusion (STABO)

May 28, 2026 updated by: Vastra Gotaland Region

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Kardiologen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Precent Akinesia
Time Frame: 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).
30 minutes post balloon occlusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in percent Akinesia
Time Frame: 30 minutes
Difference in percent Akinesia at 30 minutes compared to baseline (before balloon occlusion).
30 minutes
Difference in radial myocardial Strain
Time Frame: 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.
30 minutes
Time until recovery of radial Strain
Time Frame: 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)
30 minutes
Percent Akinesia
Time Frame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Percent Akinesia in the myocardial segments
1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Radial myocardial Strain
Time Frame: 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.
1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Global longitudinal Strain
Time Frame: 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.
1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Myocardial wall motion index
Time Frame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Myocardial wall motion index
1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Left ventricular ejection fraction
Time Frame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Left ventricular ejection fraction
1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Left ventricular stroke volume index
Time Frame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Left ventricular stroke volume index
1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Björn Redfors, Sahlgrenska Universitetssjukhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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