STEMI Clinical Trial
— UPFRONT-STEMIOfficial title:
Upfront Premedication For Reduction of Microvascular Obstruction and No-reflow in Treating ST-segment Elevation Myocardial Infarction
Angiographic no-reflow during primary PCI procedures occurs at relatively high rate (25%) and is associated with worsening of long term morbidity and mortality. The exact mechanism of no-reflow is not fully understood, yet it is believed to be multifactorial including microvascular plugging with activated platelets and thrombotic debris in addition to the microvascular dysfunction from the ischaemia-reperfusion injury. Despite a theoretical advantage of glycoprotein IIb/IIIa inhibitors (GPi) (like; Tirofiban) to suppress the intense platelets' activation/reaction; their use did not lead to a significant net benefit, because it was opposed by increased risk of bleeding. However, the bleeding that plagued GPi use was predominantly related to vascular access in the era femoral approach was the default. Moreover, there are some recent data suggesting that small intracoronary bolus of GPi was non-inferior to intravenous bolus-infusion dose with less bleeding events. This study plans to assess upfront premedication with small doses of GPi + Nitroglycerin ± Verapamil, with staged restoration of flow (repeated balloon inflation) to reduce angiographic no-reflow and CMR assessed microvascular occlusion (MVO).
Status | Not yet recruiting |
Enrollment | 626 |
Est. completion date | November 30, 2026 |
Est. primary completion date | May 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - STEMI patients with time from symptom onset of < 24 hours duration. - Large thrombus burden confirmed after initial wiring. - Radial vascular access. Exclusion Criteria: - STEMI patients receiving successful fibrinolytic therapy. - TIMI flow = 1 or TIMI thrombus grade = 3 at initial wiring. - Refusal to participate int the study, or unable to be consented (unconscious or comatose patients). - Femoral access. - Previous infarction in the same territory. - Patients receiving PTCA only for acute reperfusion and planned for CABG. - Patients with known intolerance or contraindications for CMR, such as claustrophobic or those with mechanical heart valve prothesis, or implantable non-conditional heart rhythm devices. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cairo University | Aswan Heart Centre |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy endpoint: Reducing rates of suboptimal PCI results | Sub-optimal PCI results defined as any of:
Final TIMI flow < 3, TIMI myocardial blush grade < 3, corrected TIMI flow count (cTFC) < 20, Occurrence of TIMI flow < 3 during stenting/post dilation, (no reflow) ST elevation resolution < 50% in the index lead assessed within 30m from the procedural end. |
One day (assessed by the end of the procedure) | |
Primary | Safety endpoint: Occurrence of intrahospital BARC types 3 or 5 bleedings | Occurrence of intrahospital BARC types 3 or 5 bleedings | 30 days | |
Secondary | Occurrence of slow flow/no reflow after stent deployment or stent optimization (TIMI flow < 3) | occurrence of TIMI flow < 3 after stent deployment or post stent optimization | one day (assessed by the end of the procedure) | |
Secondary | Final TIMI flow | TIMI flow at the end of the procedure | one day (assessed by the end of the procedure) | |
Secondary | Final TIMI myocardial blush grade | TIMI myocardial blush grade at the end of the procedure | One day (assessed by the end of the procedure) | |
Secondary | NT-BNP at 90 days | N-terminal pro brain natriuretic peptide | 90 days | |
Secondary | LVEF at 90 days | Left ventricular ejection fraction | 90 days | |
Secondary | MVO at 90 days assessed by CMR | Microvascular obstruction assessed by cardiac magnetic resonance assessed by 90 days | 90 days | |
Secondary | Myocardial salvage assessed by CMR | Comparing infarction size at 90 days to area at risk (AAR) in baseline CMR study | 90 days | |
Secondary | Adverse remodeling of the LV | Increase of LVEDV and LVESV by = 12% in the 90-days CMR from baseline . | 90 days |
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