|- candidate number||14994|
|- NTR Number||NTR4040|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jun-2013|
|- Secondary IDs||NL42435.078.12 |
|- Public Title||Postconditioning Rotterdam Trial|
|- Scientific Title||Additional treatment to primary PCI: effects of ischemic postconditioning after thrombectomy
|- hypothesis||The primary objective of this study is to determine whether thrombectomy combined with ischemic postconditioning after PCI leads to a smaller myocardial infarction compared to standard therapy. |
|- Healt Condition(s) or Problem(s) studied||MRI, Myocardial infarction , Primary PCI, ST-segment elevation myocardial infarction (STEMI), Postconditioning, Throbectmy|
|- Inclusion criteria||Patients are included in the study when written informed consent is given. Consecutive patients as defined above are screened for inclusion in the trial. The eligibility criteria consist of the following:|
1. Delay between onset of chest pain and PCI ≤ 6 hours in case of inferiolateral wall infarction and ≤ 12 hours in case of anterior wall infarction;
2. An occluded infarct related artery must be demonstrated (TIMI-flow 0-1).
|- Exclusion criteria||1. Younger than 18 or older than 75 years of age;|
2. Cardiogenic shock defined as sustained systolic blood pressure ≤ 80 mmHg despite fluid hydration and/or the inability to discontinue vasopressors in less than 1 hour before;
3. Post cardiac resuscitation;
4. Thrombolytic therapy in the previous week;
5. Myocardial infarction biomarkers at admission >5 times the upper limit of normal since this implies longer lasting myocardial infarction;
6. TIMI-flow >1 before intervention or TIMI-flow <2 after initial balloon inflation;
7. Significant collateral blood flow to the distal vasculature of the occluded vessel;
8. An extended myocardial infarction, as evidenced by a new episode of chest pain with new ST-segment elevations and a new CK / CK-MB peak;
9. Documented hospital admission for heart failure;
10. Known pre-existent left ventricular dysfunction measured by any technique (ejection fraction < 45% prior to current admission for myocardial infarction);
11. History of known previous myocardial infarction;
12. Prior coronary artery bypass grafting;
13. Moderate to severe cardiac valve disease;
14. Known cardiomyopathy;
15. Congenital cardiac disease;
16. Blood transfusion in the previous 24 hours;
17. Stroke or transient ischemic attack within the previous 24 hours;
18. Any contraindication for Magnetic Resonance Imaging i.e.:
• cerebrovascular clips
19. Chronic use of anti-inflammatory medication, except for the use of NSAIDs (non-steroidal anti-inflammatory drugs);
20. Serious known concomitant disease with a life expectancy of less than one year;
21. Follow-up impossible (no fixed abode, etc);
22. Previous participation in this study or any other trial within the previous 30 days.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-mei-2013|
|- planned closingdate||31-dec-2014|
|- Target number of participants||72|
|- Interventions||Primairy PCI including thrombectomy with or without ischemic postconditioning. In the ischemic postconditioning group, directly after successful thrombectomy within one minute of reflow after opening the culprit lesion, the angioplasty balloon is re-inflated 4 times for 1 minute with low-pressure (4 to 6 atm.) inflations, each separated by 1 minute of reflow. In the control group no additional intervention is performed after thrombectomy during the first 8 minutes of reperfusion.|
|- Primary outcome||Difference of myocardial infarct size between treatment groups measured on delayed enhance (DE) MRI at 3 months.|
|- Secondary outcome||The difference between treatment groups in |
• Myocardial infarct size as measured by serum CK release during the first 72 hours after PCI.
• ST segment resolution after PCI at time of return to the coronary care unit, at 60 and 90 minutes.
• Salvaged area measured as the area at risk on T2 weighed MRI minus the final infarct size on DE MRI.
• Index of microvascular resistance, true resistance and fractional flow reserve after primairy PCI
• Regional myocardial function based on a MRI segmental analysis at 3 months.
• Global left ventricular ejection fraction at 3 months measured by MRI.
• Microvascular obstruction measured by MRI at 3-5 days after PCI.
• Blush grade measured at primairy PCI.
• The occurrence within 3 months of a Major Adverse Cardiac Event defined as cardiac death, myocardial infarction, coronary bypass grafting, or a repeat percutaneous intervention of the culprit lesion.
• Concentrations of chemokines (including NT-pro-BNP) and cytokines at 3 months relative to 24 hours.
• Creatinine at admission, day 1, 2, 3 and 4.
|- Timepoints||Patients are followed up during admission as well as at 1 and 3 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Oliver C. Manintveld,|
|- CONTACT for SCIENTIFIC QUERIES|| Oliver C. Manintveld,|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus MC, Rotterdam, Thoraxcenter|
|- Brief summary||Acute myocardial infarction (AMI), is the main cause of heart failure in Western countries. Due to reduction of peri-infarct mortality, the prevalence of heart failure is increasing. In patients suffering an AMI, infarct size is a major predictor of later development of heart failure. Hence, developing novel strategies to reduce irreversible damage by myocardial ischemia-reperfusion, and thereby limiting infarct size, is an important therapeutic goal. To date the single most effective therapy remains timely reperfusion of the jeopardized ischemic myocardium by percutaneous coronary intervention (PCI). However, despite its established merits, reperfusion itself contributes to irreversible damage. Interestingly, it was recently shown that intermittent reperfusion (called “postconditioning” (POC)) following ischemia limits infarct size in patients with AMI. In addition, thrombus aspiration results in a better blush, faster ST resolution with a lower mortality rate at 1 year after primary percutaneous intervention (PCI). It is our objective to study if thrombectomy combined with POC, leads to an improved myocardial perfusion and a smaller myocardial infarct size and thus leads to better preserved left ventricular function. Magnetic Resonance Imaging (MRI) will be used to study infarct size and LV function.|
|- Main changes (audit trail)|
|- RECORD||14-jun-2013 - 8-jul-2013|