STunning After Balloon Occlusion

Vastra Gotaland Region50 enrolled

Overview

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).

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Intracoronary balloon inflationOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kardiologen

Gothenburg, Sweden

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 30 minutes post balloon occlusion

Secondary Outcomes

Difference in percent Akinesia

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

Time frame: 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.

Time frame: 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)

Time frame: 30 minutes

Percent Akinesia

Percent Akinesia in the myocardial segments

Time frame: 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.

Time frame: 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.

Central Contacts

Björn Redfors, AssocProf

CONTACT

+46 31 342 7543 Bjoern.Redfors@wlab.gu.se

Data from ClinicalTrials.gov

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