Clinical trial NCT05023629: STunning After Balloon Occlusion
Official title: STunning After Balloon Occlusion, A Single-center, Single-arm, Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Myocardial stunning
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2021-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-center, single-arm, prospective study
Primary purpose: OTHER

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Precent Akinesia
timeFrame: 30 minutes post balloon occlusion
Secondary outcomes:
measure: Difference in percent Akinesia
timeFrame: 30 minutes
measure: Difference in radial myocardial Strain
timeFrame: 30 minutes
measure: Time until recovery of radial Strain
timeFrame: 30 minutes
measure: Percent Akinesia
timeFrame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
measure: Radial myocardial Strain
timeFrame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
measure: Global longitudinal Strain
timeFrame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
measure: Myocardial wall motion index
timeFrame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
measure: Left ventricular ejection fraction
timeFrame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
measure: Left ventricular stroke volume index
timeFrame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Kardiologen
Study officials:
affiliation: Sahlgrenska Universitetssjukhus
name: Björn Redfors
role: PRINCIPAL_INVESTIGATOR
References: