Study Results
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2021-09-06
2025-12-15
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients with a significant coronary artery lesion
Balloon inflation for 90s
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Björn Redfors
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska Universitetssjukhus
Locations
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Kardiologen
Gothenburg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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v.2.0
Identifier Type: -
Identifier Source: org_study_id
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