In-hospital Versus After-discharge Complete Revascularization
NCT ID: NCT04743154
Last Updated: 2023-04-24
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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COMPLETED
NA
250 participants
INTERVENTIONAL
2018-01-20
2022-12-21
Brief Summary
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The purpose of this study is to evaluate the impact of these two different strategies in terms of hospital stay.
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Detailed Description
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Eligible non-culprit coronary arteries must be \>2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses ≥70% or between ≥50% and \<70 in proximal segments can be randomized.
Patients in the in-hospital revascularization group will undergo to non-culprit percutaneous coronary intervention (PCI) at least 24 hours after ST-segment elevation myocardial infarction. On the other hand, patients in the after-discharge group will undergo to non-culprit PCI within 4-6 weeks after STEMI.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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In-hospital complete revascularization group.
Patients will undergo to a complete revascularization of non-culprit lesions at least 24 hours after STEMI and before hospital discharge.
In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)
To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure during index admission.
After-discharge complete revascularization group.
Patients will undergo to a complete revascularization of non-culprit lesions after hospital discharge within 4-6 weeks after STEMI.
After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)
To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure after hospital discharge.
Interventions
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In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)
To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure during index admission.
After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)
To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure after hospital discharge.
Eligibility Criteria
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Inclusion Criteria
* ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
* Culprit lesion in a major native vessel, with successful primary PCI.
* Presence of at least one non-culprit lesion more than or equal to 70% of stenosis in a vessel more than 2mm of diameter or more than or equal to 50% stenosis in proximal segments.
* The patient is able to give written consent for participation in the study.
Exclusion Criteria
* Significant left main stenosis.
* Stent thrombosis.
* Chronic total occlusion.
* Severe stenosis of non-culprit vessels with distal flow less than TIMI3.
* Significant non-culprit stenosis no candidate to revascularization.
* Presence of valvulopathy candidate for cardiac surgery.
* Cardiogenic shock status at admission.
* The patient is not able to give written consent for participation in the study.
18 Years
90 Years
ALL
No
Sponsors
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Hospital General Universitario de Valencia
OTHER
Responsible Party
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Eva Rumiz González
Principal investigator
Principal Investigators
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Eva Rumiz Gonzalez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario de Valencia
Locations
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Hospital General Universitario de Valencia
Valencia, , Spain
Countries
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References
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Other Identifiers
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HGUValencia
Identifier Type: -
Identifier Source: org_study_id
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