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Набира участници Фаза 4 NCT07536802

Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: ST-Segment Elevation Myocardial Infarction (STEMI) No-Reflow Phenomenon Coronary Slow Flow Acute Myocardial Infarction

Спонсор: National Institute of Cardiovascular Diseases, Pakistan

Налично на: БГ
Обобщение
Primary objective of the study is to evaluate the impact of adenosine pre-medication on incidence of slow flow/no-reflow after primary percutaneous coronary intervention.
Описание
Background: Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for ST-segment elevation myocardial infarction (STEMI); however, optimal myocardial perfusion is not achieved in all patients due to the slow flow/no-reflow phenomenon. This condition, defined as inadequate myocardial perfusion despite patent epicardial arteries, is associated with worse clinical outcomes. Adenosine, owing to its vasodilatory, anti-inflammatory, and antiplatelet properties, may improve microvascular perfusion. While its use during PCI is established, its prophylactic role prior to PCI remains unclear. Study Design: This is a multicenter, single-blinded, randomized controlled trial conducted at NICVD Karachi and its satellite centers (Liyari and Larkana) over 12 months. A total of 1,148 STEMI patients undergoing primary PCI will be randomized in a 1:1 ratio using block randomization. Intervention: Intervention Group: Intracoronary adenosine pre-medication (2 mg for left coronary artery, 1 mg for right coronary artery, diluted in 20 mL normal saline) plus standard care. Control Group: Standard pharmacological management alone. Participants: Adults (≥18 years) with STEMI undergoing primary PCI. Key exclusions include cardiogenic shock, heart block, adenosine allergy, and refusal to consent. Outcomes: Primary Outcome: Incidence of slow flow/no-reflow (TIMI flow grade 0-II). Secondary Outcome: Myocardial Blush Grade (0-III). Safety: Potential adverse effects such as transient bradycardia or heart block will be managed per institutional protocols. Data and Analysis: Baseline, procedural, and outcome data will be collected. Statistical analysis will be performed using SPSS, with appropriate tests applied for continuous and categorical variables. A p-value ≤0.05 will be considered significant.
Кой може да участва
Inclusion Criteria: * All patients with acute STEMI undergoing primary PCI * Patients of either sex, ≥18 years of age. Exclusion Criteria: * STEMI patients with cardiogenic shock at presentation * Patients with heart block * Allergy to adenosine * Patients refuse to give consent for participation
Интервенции
Adenosine pre-medication
DRUG
Standard care
OTHER
Места на провеждане 2
Pakistan (2)
National Institute of Cardiovascular Diseases
Karachi , Sindh
Muhammad Nauman Khan, FCPS
National Institute of Cardiovascular Diseases
Karachi , Sindh
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
01.06.2025
Крайна дата
31.12.2026
Регистрационен номер
NCT07536802
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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