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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05023629
Other study ID # v.2.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 6, 2021
Est. completion date December 15, 2025

Study information

Verified date October 2022
Source Vastra Gotaland Region
Contact Björn Redfors, AssocProf
Phone +46 31 342 7543
Email Bjoern.Redfors@wlab.gu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 15, 2025
Est. primary completion date July 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Sweden Kardiologen Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 30 minutes post balloon occlusion
Secondary Difference in percent Akinesia Difference in percent Akinesia at 30 minutes compared to baseline (before balloon occlusion). 30 minutes
Secondary 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. 30 minutes
Secondary 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) 30 minutes
Secondary Percent Akinesia Percent Akinesia in the myocardial segments 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Secondary Radial myocardial Strain 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
Secondary Global longitudinal Strain 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
Secondary Myocardial wall motion index Myocardial wall motion index 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Secondary Left ventricular ejection fraction Left ventricular ejection fraction 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Secondary Left ventricular stroke volume index Left ventricular stroke volume index 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
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