|- candidate number||10587|
|- NTR Number||NTR3164|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-nov-2011|
|- Secondary IDs||2011/197 METC VUmc|
|- Public Title||PREDICT-MVO.|
|- Scientific Title||Pressure-Flow Measurements Directly after Primary PCI to Predict Late Occurrence of Microvascular Obstruction.|
|- hypothesis||We hypothesize that a combined intracoronary pressure-flow measurement directly after percutaneous coronary intervention is a measure for predicting the occurrence of microvascular obstruction in the days following the acute event.|
|- Healt Condition(s) or Problem(s) studied||Acute myocardial infarction , Atherosclerosis , Microvascular obstruction|
|- Inclusion criteria||1. Patients with STEMI;|
2. Presenting at cath lab < 6 hours after onset of symptoms.
|- Exclusion criteria||1. Previous MI in same artery;|
2. Significant three-vessel disease (lesions >70%);
4. Unsuccessful primary PCI (TIMI 0-1);
5. Cardiogenic shock;
6. Extreme fear and severe chest pain;
7. Poor kidney function (eGFR < 30 mg/ml/min);
8. Refusal or inability to give informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||21-nov-2011|
|- planned closingdate||21-nov-2012|
|- Target number of participants||60|
|- Interventions||Intracoronary pressure-flow measurements (MVRI).|
|- Primary outcome||1. MVRI;|
|- Secondary outcome||1. ST-resolution on ECG;|
2. Blood samples.
|- Timepoints||T=0, T=1, T=4, T=7, T=90.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| P.F.A. Teunissen|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Niels Royen, van|
|- Sponsor/Initiator ||Volcano Precision Guided Therapy|
(Source(s) of Monetary or Material Support)
|Volcano Precision Guided Therapy|
|- Brief summary||Patients with acute STEMI that are Presented at catheterization laboratory within 6 hours after onset of symptoms. Directly following successful revascularization and stent-placement, using a combowire intracoronary resistance measurements will be done distal to the coronary stent. Using the ComboMap Pressure and Flow System simultaneous pressure and Doppler flow velocity will be recorded. A second resistance measurement will be done in a controlateral artery without a stenosis to serve as a reference value. At day 4 and day 90 after the acute event, a cardiac perfusion PET scan will be performed. Standard care includes angiographic measurements as well as electrocardiography, Cardioac magnetic resonance (CMR) examination and also blood samples will be taken.
Main study parameters/endpoints:
The main study endpoints are the resistance values as measured with the combowire and the total infarct size and MVO as measured by CMR.
Secondary endpoints are all other parameters measured as well as adverse events.
|- Main changes (audit trail)|
|- RECORD||28-nov-2011 - 7-dec-2011|