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Bloodless Reperfusion in Acute Myocardial Infarction

Bloodless Reperfusion in Acute Myocardial Infarction Pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20782
Enrollment
Unknown
Registered
2018-10-23
Start date
2019-01-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Interventions

The bloodless reperfusion technique will be evuluated: A adequately sized semi-compliant balloon will be inflated at low pressure (2-4atm) proximal to the occlusion. Thereafter a double lumen microc

Sponsors

Amsterdam University Medical Centers, location VUmc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with an acute STEMI are eligible when they meet the following inclusion criteria: Symptom onset < 6 hours, Thrombolysis In Myocardial Infarction (TIMI) 0 flow, and at least 1 intermediate lesion in a non-infarct related artery.

Exclusion criteria

Exclusion criteria: Major exclusion criteria are cardiogenic shock and a history of prior myocardial infarction or coronary artery bypass grafting (CABG).

Design outcomes

Primary

MeasureTime frame
30-day major cardiac and cerebral events (MACCE), including peri-procedural complications—

Secondary

MeasureTime frame
Pre- and post-reperfusion coronary wedge pressure (CWP) and its association with IS and MVO as measured with cMR Pre- and post-reperfusion coronary wedge pressure (CWP) and its association with left ventricular ejection fraction and volumes as measured with (2D and 3D) echocardiography Post-reperfusion index of microvascular resistance (iMR) and its association with cMR indices, electrocardiography (i.e. ST-segment recovery), and echocardiography Pre- and post-reperfusion CWP and iMR and their association with left ventricular end-diastolic pressure (LVEDP) Pre- and post-reperfusion CWP and iMR and their association with serum biomarkers (cardiac troponin, lactate) Post-reperfusion fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) and their association with IS and MVO as measured with cMR Post-reperfusion FFR and iFR and their association with left ventricular ejection fraction and volumes as measured with (2D and 3D) echocardiography Post-reperfusion FFR and iFR and their association with cMR indices, electrocardiography (i.e. ST-segment recovery), and echocardiography Post-reperfusion FFR and iFR and their association with left ventricular end-diastolic pressure (LVEDP) Post-reperfusion FFR and iFR and their association with serum biomarkers (cardiac troponin, lactate)—

Contacts

Public ContactAlexander Nap

VUmc

a.nap@vumc.nltel: +31 20 4444444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)