STunning After Balloon Occlusion

NCT05023629 | Unknown

• 1 other identifier: v.2.0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention; Myocardial stunning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Difference in percent Akinesia

  30 minutes

• Difference in radial myocardial Strain

  30 minutes

• Time until recovery of radial Strain

  30 minutes

• Percent Akinesia

  1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours

• Radial myocardial Strain

  1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours

Study Arms (1)

Patients with a significant coronary artery lesion

OTHER

Balloon inflation for 90s

Other: Intracoronary balloon inflation

Interventions

Intracoronary balloon inflation OTHER

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

Patients with a significant coronary artery lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• Stable CAD with indication for PCI of a lesion in either of the following coronary segments:
• or 7 (proximal or mid left anterior descending coronary artery)
• (Proximal left circumflex coronary artery)
• or 2 (proximal right coronary artery)
• Normal cardiac function in the myocardial segments subtended by the target vessel, as assessed by echocardiography at the time of coronary angiography.
• Written informed consent obtained.

You may not qualify if:

• Pre-existing heart failure
• Known pre-existing irreversible regional or global wall motion abnormalities affecting the myocardial segments subtended by the target vessel.
• Severe valvulopathy
• Thrombolysis In Myocardial Infarction (TIMI) flow \<3 in the target vessel.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Kardiologen

Gothenburg, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Stunning

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Björn Redfors

  Sahlgrenska Universitetssjukhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Björn Redfors, AssocProf

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A single-center, single-arm, prospective study

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 26, 2021
• Study Start: September 6, 2021
• Primary Completion: July 15, 2023
• Study Completion: December 15, 2025
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)