STunning After Balloon Occlusion

NCT ID: NCT05023629

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-06

Study Completion Date

2025-12-15

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single-center, single-arm, prospective study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with a significant coronary artery lesion

Balloon inflation for 90s

Group Type OTHER

Intracoronary balloon inflation

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Björn Redfors

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Universitetssjukhus

Locations

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Kardiologen

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Björn Redfors, AssocProf

Role: CONTACT

+46 31 342 7543

Facility Contacts

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Björn S Redfors, PhD, MD

Role: primary

+46313427543

Other Identifiers

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v.2.0

Identifier Type: -

Identifier Source: org_study_id

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