Myocardial InfarctionNCT00351247
Postconditioning in Primary PCI and Direct Stenting
A study testing Postconditioning in people with Myocardial Infarction, run by Sheba Medical Center at 1 site in Israel.
Trial summary
To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Postconditioning
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2006to May 2007
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is > 21 years of age and provides informed consent.
- Evidence of AMI as indicated by signs and symptoms. Diagnosis of ST-segment elevation AMI will be based on chest pain for >30 minutes and ST-segment elevation of >1mV in 2 limb lead or >2mV in 2 anterior leads contiguous leads on the 12-lead ECG.
- Eligible to undergo primary PCI.
- Symptom duration is < 6 hours prior to primary PCI.
- Angiographic: The target lesion in the infarct related artery (IRA) should be occluded (TIMI).
- Angiographic: The target lesion in the proximal or middle segment of a native major coronary artery (LAD, RCA or dominant CX).
- Angiographic: The target lesion should be suitable for PTCA or stenting.
- Angiographic: The IRA occlusion will be successfully opened by stenting with TIMI 2-3
Who cannot join
- Unwillingness to participate.
- Prior Acute MI
- Cardiac arrest or Killip score III-IV
- Women with known pregnancy.
- Active significant bleeding.
- Known allergy for aspirin, ticlopidine and clopidogrel, or heparin.
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- Chronic renal failure with creatinine > 2 mg/dl
- Other medical illness associated with limited life expectancy or that may cause the patient to be non-compliant with the protocol.
- Current participation in other trials using investigational drugs or devices.
- Contraindications to MRI including: arrythmias, cardiac pacer, brain aneurysm clips, cochlear implants, nerve stimulator.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Tel HaShomer
Victor Guetta, MD, 972-52-6667127, victor.Guetta@health.sheba.gov.il
Elad Maor, MD, 972-52-3691613, elad.maor@gmail.com
About this study
Official title: Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting
To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.
Read the detailed description
Sample size: 45 subjects
Site Locations: Sheba medical center
Patients: Patients presenting with an acute MI with onset of symptoms 6h, and planned to undergo primary PCI will be included. The target lesion should be located in the proximal or middle segment of a main native coronary artery, and should be suitable for percutaneous intervention.
Primary Objective: To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.
Primary Endpoint:
- ST segment resolution.
- Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
- Infarct size estimation by cardiac enzymes and cardiac MRI.
Secondary endpoints:
- Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
Methods:
- ECG at baseline, immediately after procedure, 90 and 180 minutes after the procedure and 6-24 hours after intervention.
- Core laboratory angiography measurements of TIMI flow, corrected TIMI Frame count, myocardial blush score and left ventricular angiography.
- Myocardial enzymes measurements: every 4 hours in the first 24 hours and every 6 hours in the following 48 hours.
- Left ventricular ejection fraction and wall motion score determined by echocardiography.
- Cardiac MRI estimation of infarct size. • Clinical follow-up at 30 and 90 days post procedure.
Follow-up:
- Follow up at 30 days: Clinical.
- Clinical Follow up \& Cardiac MRI at 90 days.
- Conditions
- Myocardial Infarction
- Being tested
- Postconditioning
- Keywords
- Myocardial Infarction, Primary PCI, Postconditioning, MRI
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostconditioningProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
ST segment resolution.
Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
Infarct size estimation by cardiac enzymes and cardiac MRI.
Secondary outcomes (1)
Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2006 (estimated)
- Study startJul 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Victor Guetta, MD, Principal investigator, Sheba Medical CenterJonathan Leor, MD, Principal investigator, Neufeld Cardiac Research CenterElad Maor, MD, Principal investigator, Neufeld Cardiac Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351247
- Sponsor's protocol ID
- SHEBA-06-4066-VG-CTIL
- Status last verified
- Jul 2006
- First submitted
- 11 Jul 2006
- Last updated
- 12 Jul 2006
- Results posted
- No
Publications
Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.
PubMed 16186417Zhao ZQ, Corvera JS, Halkos ME, Kerendi F, Wang NP, Guyton RA, Vinten-Johansen J. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H579-88. doi: 10.1152/ajpheart.01064.2002.
PubMed 12860564
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting
- ClinicalTrials.gov ID
- NCT00351247
- Acronym / sponsor ID
- SHEBA-06-4066-VG-CTIL
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Primary PCI, Postconditioning, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2006
- Study completion
- May 2007
- First posted
- 12 Jul 2006 (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.
To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.
Detailed description
Sample size: 45 subjects
Site Locations: Sheba medical center
Patients: Patients presenting with an acute MI with onset of symptoms 6h, and planned to undergo primary PCI will be included. The target lesion should be located in the proximal or middle segment of a main native coronary artery, and should be suitable for percutaneous intervention.
Primary Objective: To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.
Primary Endpoint:
- ST segment resolution.
- Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
- Infarct size estimation by cardiac enzymes and cardiac MRI.
Secondary endpoints:
- Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
Methods:
- ECG at baseline, immediately after procedure, 90 and 180 minutes after the procedure and 6-24 hours after intervention.
- Core laboratory angiography measurements of TIMI flow, corrected TIMI Frame count, myocardial blush score and left ventricular angiography.
- Myocardial enzymes measurements: every 4 hours in the first 24 hours and every 6 hours in the following 48 hours.
- Left ventricular ejection fraction and wall motion score determined by echocardiography.
- Cardiac MRI estimation of infarct size. • Clinical follow-up at 30 and 90 days post procedure.
Follow-up:
- Follow up at 30 days: Clinical.
- Clinical Follow up \& Cardiac MRI at 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is > 21 years of age and provides informed consent.
- Evidence of AMI as indicated by signs and symptoms. Diagnosis of ST-segment elevation AMI will be based on chest pain for >30 minutes and ST-segment elevation of >1mV in 2 limb lead or >2mV in 2 anterior leads contiguous leads on the 12-lead ECG.
- Eligible to undergo primary PCI.
- Symptom duration is < 6 hours prior to primary PCI.
- Angiographic: The target lesion in the infarct related artery (IRA) should be occluded (TIMI).
Key exclusion criteria (10 listed)
- Unwillingness to participate.
- Prior Acute MI
- Cardiac arrest or Killip score III-IV
- Women with known pregnancy.
- Active significant bleeding.
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 |
|---|---|---|
| Postconditioning | Procedure or surgery | – |
Primary outcome
ST segment resolution.
Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
Infarct size estimation by cardiac enzymes and cardiac MRI.
1 secondary outcome
Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2006.
- Background: PubMed 16186417Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.
- Background: PubMed 12860564Zhao ZQ, Corvera JS, Halkos ME, Kerendi F, Wang NP, Guyton RA, Vinten-Johansen J. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H579-88. doi: 10.1152/ajpheart.01064.2002.
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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.
Victor Guetta, MD principal investigator
Sheba Medical Center
Jonathan Leor, MD principal investigator
Neufeld Cardiac Research Center
Elad Maor, MD principal investigator
Neufeld Cardiac Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postconditioning in people with Myocardial Infarction, run by Sheba Medical Center at 1 site in Israel.
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 8 inclusion and 10 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 12 Jul 2006. 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 Israel. 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.
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 Victor Guetta, MD (972-52-6667127, victor.Guetta@health.sheba.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ST segment resolution.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00351247, which also lists 2 linked publications.
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 12 Jul 2006.