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.
ID
Bron
Verkorte titel
Aandoening
myocardial infarction, primairy PCI, STEMI, thrombectmy, postconditioning, MRI
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Difference of myocardial infarct size between treatment groups measured on delayed enhance (DE) MRI at 3 months.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Patients are followed up during admission as well as at 1 and 3 months.
Onderzoeksproduct en/of interventie
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.
Publiek
Erasmus University Medical Center
‘s-Gravendijkwal 230
Oliver C. Manintveld,
Rotterdam 3015 CE
The Netherlands
+31 (0)10 703 5407
o.manintveld@erasmusmc.nl
Wetenschappelijk
Erasmus University Medical Center
‘s-Gravendijkwal 230
Oliver C. Manintveld,
Rotterdam 3015 CE
The Netherlands
+31 (0)10 703 5407
o.manintveld@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.:
• pacemaker
• cerebrovascular clips
• claustrophobia
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3872 |
| NTR-old | NTR4040 |
| CCMO | NL42435.078.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |