NCT05393557Not yet recruiting
Upfront Premedication For Reduction of Microvascular Obstruction and No-reflow in Treating ST-segment Elevation Myocardial Infarction
Source: ClinicalTrials.gov · Last updated 31 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 626 (estimated)
- First submitted
- 23 May 2022
- Start date
- 1 Jan 2024
- Primary completion date
- 31 May 2026
- Lead sponsor
- Cairo University
- Diseases
- Coronary artery disease
- NCT number
- NCT05393557
What you commit to
- Study type: Interventional
- Planned participants: 626
- From 1 Jan 2024 to the primary completion date, 31 May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- STEMI patients receiving successful fibrinolytic therapy.
- Previous infarction in the same territory.
- Patients receiving PTCA only for acute reperfusion and planned for CABG.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- STEMI patients with time from symptom onset of \< 24 hours duration.
- Large thrombus burden confirmed after initial wiring.
- Radial vascular access.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.