Myocardial InfarctionPhase 4OPTIMASTRATEGYNCT01462188
Optimizing Infarct Size by Transforming Emergent Stenting Into an Elective Procedure Study
A Phase 4 study testing Immediate stenting and Delayed stenting in people with Myocardial Infarction, run by Marco Valgimigli at 1 site in Italy.
Trial summary
The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely thrombotic lesion may determine distal embolisation of thrombotic material therefore deteriorating myocardial perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Immediate stenting and Delayed stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to Oct 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chest pain for >30 min with ST-segment elevation of one mm or more in 2 or more contiguous ECG leads or with presumably new left bundle-branch block
- admission either within 12 h of symptom onset or between 12 and 24 h with evidence of continuing ischaemia
Who cannot join
- the exclusion criteria will include history of bleeding diathesis or documented allergy/intolerance or contraindication to clopidogrel or ticlopidine or prasugrel
- inability to assume an oral P2Y12 receptor blocker on a consecutive daily basis for a minimum of 6 months, or to heparin or aspirin
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
U.O. Cardiologia
Ferrara, Emilia-Romagna, 44100
Alessandro Dal Monte, MD, 3487243479 ext. +39, dalmo_it@yahoo.it
About this study
Official title: Immediate Versus Delayed Stenting in Patients With ST-Elevation Myocardial Infarction Undergoing Mechanical Intervention
The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely thrombotic lesion may determine distal embolisation of thrombotic material therefore deteriorating myocardial perfusion.
Read the detailed description
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.
- Conditions
- Myocardial Infarction
- Being tested
- Immediate stenting, Delayed stenting
- Keywords
- ST-segment elevation myocardial infarction, Primary angioplasty, stent
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate stentingProcedure or surgery
Primary coronary stenting
Delayed stentingProcedure or surgery
Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase
| Study group | Role | What they receive |
|---|---|---|
| Immediate stenting | Active comparator | 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. Receives: Procedure: Immediate stenting |
| Delayed stenting | Experimental | 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. Receives: Procedure: Delayed stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial blush grade (MBG) equal or greater than 2
The MBG will be estimated visually by 2 experienced observers, as previously described.
Measured: post-procedure
Secondary outcomes (7)
ST segment elevation resolution
Cumulative ST segment elevation in all leads will be quantified before and after the procedure and expressed as percentage
Measured: 30 minutes after the procedure
ST segment elevation Resolution
Measured: 90 minutes after the procedure
infarct size
Infarct size will be quantified by MRI
Measured: 5 days
Infarct size
Infarct size will be quantified by MRI
Measured: 6 months
microvascular obstruction
microvascular obstruction will be quantified by MRI
Measured: 5 days
microvascular obstruction
microvascular obstruction will be quantified by MRI
Measured: 6 months
Mortality
overall and cardiac mortality will be assessed up to 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Valgimigli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco Valgimigli, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462188
- Sponsor's protocol ID
- TRAPS-09-I
- Acronym
- OPTIMASTRATEGY
- Status last verified
- Oct 2011
- First submitted
- 24 Oct 2011
- Last updated
- 31 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Stenting in Patients With ST-Elevation Myocardial Infarction Undergoing Mechanical Intervention
- ClinicalTrials.gov ID
- NCT01462188
- Acronym / sponsor ID
- OPTIMASTRATEGY / TRAPS-09-I
- Conditions
- Myocardial Infarction
- Keywords
- ST-segment elevation myocardial infarction, Primary angioplasty, stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marco ValgimigliUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 31 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely thrombotic lesion may determine distal embolisation of thrombotic material therefore deteriorating myocardial perfusion.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate stenting | Active comparator | Procedure: Immediate stentingPatients 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. |
| Delayed stenting | Experimental | Procedure: Delayed stentingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chest pain for >30 min with ST-segment elevation of one mm or more in 2 or more contiguous ECG leads or with presumably new left bundle-branch block
- admission either within 12 h of symptom onset or between 12 and 24 h with evidence of continuing ischaemia
Key exclusion criteria (7 listed)
- the exclusion criteria will include history of bleeding diathesis or documented allergy/intolerance or contraindication to clopidogrel or ticlopidine or prasugrel
- inability to assume an oral P2Y12 receptor blocker on a consecutive daily basis for a minimum of 6 months, or to heparin or aspirin
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate stentingPrimary coronary stenting | Procedure or surgery | Immediate stenting |
| Delayed stentingCoronary stenting 3 to 7 days after having reopened the vessel in the acute phase | Procedure or surgery | Delayed stenting |
Primary outcome
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.
7 secondary outcomes
ST segment elevation resolution
Time frame: 30 minutes after the procedure
ST segment elevation Resolution
Time frame: 90 minutes after the procedure
infarct size
Time frame: 5 days
Infarct size
Time frame: 6 months
microvascular obstruction
Time frame: 5 days
microvascular obstruction
Time frame: 6 months
Mortality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immediate stenting and Delayed stenting in people with Myocardial Infarction, run by Marco Valgimigli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Dal Monte, MD (3487243479 ext. +39, dalmo_it@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial blush grade (MBG) equal or greater than 2 (time frame: post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2011.