Optimizing Infarct Size by Transforming Emergent Stenting Into an Elective Procedure Study (OPTIMASTRATEGY)
|ClinicalTrials.gov Identifier: NCT01462188|
Recruitment Status : Unknown
Verified October 2011 by Marco Valgimigli, Università degli Studi di Ferrara.
Recruitment status was: Recruiting
First Posted : October 31, 2011
Last Update Posted : October 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Procedure: Immediate stenting Procedure: Delayed stenting||Phase 4|
In the setting of largely thrombotic lesions such as those treated in the context of primary PCI, stenting often results in distal micro and macro-embolisation which hampers coronary flow and microvascular recovery. Interestingly in some of these studies comparing BMS versus balloon angioplasty an early hazard associated to the use of stent has been reported.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Immediate Versus Delayed Stenting in Patients With ST-Elevation Myocardial Infarction Undergoing Mechanical Intervention|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||October 2015|
Active Comparator: 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.
Procedure: Immediate stenting
Primary coronary stenting
Experimental: 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.
Procedure: Delayed stenting
Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase
- Myocardial blush grade (MBG) equal or greater than 2 [ Time Frame: post-procedure ]The MBG will be estimated visually by 2 experienced observers, as previously described.
- ST segment elevation resolution [ Time Frame: 30 minutes after the procedure ]Cumulative ST segment elevation in all leads will be quantified before and after the procedure and expressed as percentage
- ST segment elevation Resolution [ Time Frame: 90 minutes after the procedure ]
- infarct size [ Time Frame: 5 days ]Infarct size will be quantified by MRI
- Infarct size [ Time Frame: 6 months ]Infarct size will be quantified by MRI
- microvascular obstruction [ Time Frame: 5 days ]microvascular obstruction will be quantified by MRI
- microvascular obstruction [ Time Frame: 6 months ]microvascular obstruction will be quantified by MRI
- Mortality [ Time Frame: 6 months ]overall and cardiac mortality will be assessed up to 6 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462188
|Contact: Alessandro Dal Monte, MD||3487243479 ext +email@example.com|
|Contact: Marco Valgimigli, MD, PhD||3356478877 ext +firstname.lastname@example.org|
|Ferrara, Emilia Romagna, Italy, 44100|
|Contact: Alessandro Dal Monte, MD 3487243479 ext +39 email@example.com|