STunning After Balloon Occlusion (STABO)

Vastra Gotaland Region

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Other: Intracoronary balloon inflation

Study type: Interventional

Funder types: Other

Identifiers

NCT05023629

v.2.0

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Patients with a significant coronary artery lesion

Other group

Description:

Balloon inflation for 90s

Treatment:

Other: Intracoronary balloon inflation