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PREDICT-MVO.


- candidate number10587
- NTR NumberNTR3164
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-nov-2011
- Secondary IDs2011/197 METC VUmc
- Public TitlePREDICT-MVO.
- Scientific TitlePressure-Flow Measurements Directly after Primary PCI to Predict Late Occurrence of Microvascular Obstruction.
- ACRONYMPREDICT-MVO
- hypothesisWe 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) studiedAcute myocardial infarction , Atherosclerosis , Microvascular obstruction
- Inclusion criteria1. Patients with STEMI;
2. Presenting at cath lab < 6 hours after onset of symptoms.
- Exclusion criteria1. Previous MI in same artery;
2. Significant three-vessel disease (lesions >70%);
3. CABG;
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 receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 21-nov-2011
- planned closingdate21-nov-2012
- Target number of participants60
- InterventionsIntracoronary pressure-flow measurements (MVRI).
- Primary outcome1. MVRI;
2. PET;
3. MRI.
- Secondary outcome1. ST-resolution on ECG;
2. Blood samples.
- TimepointsT=0, T=1, T=4, T=7, T=90.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES P.F.A. Teunissen
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Niels Royen, van
- Sponsor/Initiator Volcano Precision Guided Therapy
- Funding
(Source(s) of Monetary or Material Support)
Volcano Precision Guided Therapy
- PublicationsN/A
- Brief summaryPatients 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)
- RECORD28-nov-2011 - 7-dec-2011


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