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.
ID
Bron
Verkorte titel
Aandoening
atherosclerosis
acute myocardial infarction
microvascular obstruction
Ondersteuning
Excelsiorlaan 41
B - 1930 Zaventem
Belgium
Phone: + 32 2 679 10 76
Fax: + 32 2 679 10 72
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. MVRI;<br>
2. PET;<br>
3. MRI.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
T=0, T=1, T=4, T=7, T=90.
Onderzoeksproduct en/of interventie
Intracoronary pressure-flow measurements (MVRI).
Publiek
de Boelelaan 1117
P.F.A. Teunissen
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443977
pf.teunissen@vumc.nl
Wetenschappelijk
de Boelelaan 1117
P.F.A. Teunissen
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443977
pf.teunissen@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with STEMI;
2. Presenting at cath lab < 6 hours after onset of symptoms.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3016 |
| NTR-old | NTR3164 |
| Ander register | METC VUmc : 2011/197 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |