STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance
NCT ID: NCT04775914
Last Updated: 2023-12-19
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
2500 participants
INTERVENTIONAL
2021-04-01
2031-02-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
As a second randomization to the iPOST2 trial (ID: H-180512561,NCT03787745) patients are randomized 1:1 to either a) receiving ultrasound guidance before and after stent placement or b) no ultrasound, independently of randomization in the iPOST2 trial. The iPOST2 trial was initiated February 2019.
TREATMENT
NONE
Study Groups
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PCI standard
PCI + Ischemic conditioning
IPOST is repeated for 4 cycles (60 sec obstruction followed by 60 sec perfusion each) and followed by stent implantation with a 1.1/1.0 ratio of stent diameter/reference vessel diameter and a stent length sufficient to cover the entire lesion from healthy to healthy area of the vessel. During the first cycle of re-occlusion of full vessel occlusion is secured by a small injection of contrast.
PCI standard + ischemic conditioning
PCI + Ischemic conditioning
IPOST is repeated for 4 cycles (60 sec obstruction followed by 60 sec perfusion each) and followed by stent implantation with a 1.1/1.0 ratio of stent diameter/reference vessel diameter and a stent length sufficient to cover the entire lesion from healthy to healthy area of the vessel. During the first cycle of re-occlusion of full vessel occlusion is secured by a small injection of contrast.
Stent with ultrasound
Stent with ultrasound
IVUS catheters are to be advanced at least 20 mm distal to the culprit lesion. After administration of intracoronary nitroglycerine, an IVUS-pullback is to be performed at 0.5mm/second using a commercially available imaging system. Stent size and landing zones are decided based on the IVUS.
Stent without ultrasound
Stent with ultrasound
IVUS catheters are to be advanced at least 20 mm distal to the culprit lesion. After administration of intracoronary nitroglycerine, an IVUS-pullback is to be performed at 0.5mm/second using a commercially available imaging system. Stent size and landing zones are decided based on the IVUS.
Interventions
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PCI + Ischemic conditioning
IPOST is repeated for 4 cycles (60 sec obstruction followed by 60 sec perfusion each) and followed by stent implantation with a 1.1/1.0 ratio of stent diameter/reference vessel diameter and a stent length sufficient to cover the entire lesion from healthy to healthy area of the vessel. During the first cycle of re-occlusion of full vessel occlusion is secured by a small injection of contrast.
Stent with ultrasound
IVUS catheters are to be advanced at least 20 mm distal to the culprit lesion. After administration of intracoronary nitroglycerine, an IVUS-pullback is to be performed at 0.5mm/second using a commercially available imaging system. Stent size and landing zones are decided based on the IVUS.
Eligibility Criteria
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Inclusion Criteria
* Acute onset of chest pain with \<12 hours duration
* STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior AMI.
Exclusion Criteria
Potential pregnancy Inability to understand information in order to provide informed consent Unwillingness to consent Spontaneous coronary artery dissection Time from symptoms inset to PPCI \> 12 hours Culprit in bypass graft Other reason
18 Years
ALL
No
Sponsors
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Thomas Engstrom
OTHER
Responsible Party
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Thomas Engstrom
Professor
Principal Investigators
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Thomas Engstrøm, MD PhD DMSci
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Jacob Lønborg, MD PhD DMSci
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Francis Joshi, Md, PhD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Locations
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Heart Center, Rigshospitalet
Copenhagen, Capital Region, Denmark
Countries
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Central Contacts
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Facility Contacts
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Thomas Engstrom, MD PhD DSci
Role: primary
Jacob Lønborg
Role: backup
Other Identifiers
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H-18051256b
Identifier Type: -
Identifier Source: org_study_id