Optimizing Infarct Size by Transforming Emergent Stenting Into an Elective Procedure Study
NCT ID: NCT01462188
Last Updated: 2011-10-31
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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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2011-10-31
2015-10-31
Brief Summary
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Detailed Description
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Thus, investigators hypothesize in this protocol that refraining from stenting during the acute phase of ST segment myocardial infarction is safe and associated to improved myocardial recovery as compared to acute stenting.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Immediate stenting
Patients being randomized to the immediate stenting arm will be managed according to the guidelines. Irrespective of TIMI flow at presentation, investigators will be requested to thrombus aspirate immediately after successful wiring of the culprit vessel followed by direct stenting. In cases where insertion of thrombus removal catheter and/or direct stenting is not successful, balloon angioplasty will be allowed.
Immediate stenting
Primary coronary stenting
Delayed stenting
Patients being randomized to the delayed/staged stenting arm will be managed with the aim to obtain stable TIMI 3 flow with no considerations given at the percentage of residual stenosis at the culprit lesion.
In patients presenting with TIMI 3 flow, investigators will be left free to wire the vessel and proceed to thrombus aspiration to decrease thrombus burden in the culprit lesion or to leave the vessel untreated at the time of index PCI. Patients presenting with suboptimal TIMI flow (i.e. less than 3), investigators are required to wire the vessel and thrombus aspirate. If stable (persisting for at least 5 minutes) TIMI 3 flow is obtained, investigators are requested to stop the procedure. The goal is to achieve s table TIMI 3 flow with no considerations given to the percentage of residual stenosis. Stenting in this arm will be allowed only on a bail-out strategy.
Delayed stenting
Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase
Interventions
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Immediate stenting
Primary coronary stenting
Delayed stenting
Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase
Eligibility Criteria
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Inclusion Criteria
* admission either within 12 h of symptom onset or between 12 and 24 h with evidence of continuing ischaemia
Exclusion Criteria
* uncontrolled hypertension (systolic or diastolic arterial pressure \>180 mmHg or 120, respectively, despite medical therapy)
* limited life expectancy, e.g. neoplasms, others
* inability to obtain informed consent
* pregnancy
* patients were not enrolled if they were clinically unstable, presented with severe arrhythmia, or had known contraindications to CMR (claustrophobia, pacemakers, or implantable defibrillator devices)
18 Years
ALL
No
Sponsors
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Marco Valgimigli
OTHER
Responsible Party
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Marco Valgimigli
Head of the Catheterization laboratory
Locations
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U.O. Cardiologia
Ferrara, Emilia-Romagna, Italy
Countries
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Central Contacts
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Facility Contacts
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Alessandro Dal Monte, MD
Role: primary
Other Identifiers
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TRAPS-09-I
Identifier Type: -
Identifier Source: org_study_id