STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance

Официальное название

The STEMI Optimization Trial - Ischemic Postconditioning (DANAMI4-iPOST) and Intravascular Ultrasound Guided PCI in STEMI (DANAMI4-iSTEMI)

Обзор

The purpose of is study is to investigate whether ischemic postconditioning (iPOST) and intravascular ultrasound-guided (IVUS) percutaneous coronary intervention (PCI) improve the clinical outcome of patients with ST-segment elevation myocardial infarction treated with primary PCI.

Вмешательства

• Процедура PCI + Ischemic conditioning
  IPOST is repeated for 4 cycles (60 sec obstruction followed by 60 sec perfusion each) and followed by stent implantation with a 1.1/1.0 ratio of stent diameter/reference vessel diameter and a stent length sufficient to cover the entire lesion from healthy to healthy area of the vessel. During the first cycle of re-occlusion of full vessel occlusion is secured by a small injection of contrast.
• Процедура Stent with ultrasound
  IVUS catheters are to be advanced at least 20 mm distal to the culprit lesion. After administration of intracoronary nitroglycerine, an IVUS-pullback is to be performed at 0.5mm/second using a commercially available imaging system. Stent size and landing zones are decided based on the IVUS.

Первичные конечные точки

• iPOST [Срок оценки: Until expected number of events are adjudicated up til 3 years]
• iSTEMI (IVUS) [Срок оценки: Until expected number of events are adjudicated up til 3 years]

Вторичные конечные точки (12)

• iSTEMI (IVUS) [Срок оценки: Until expected number of events are adjudicated 3 years]
• iSTEMI (IVUS) [Срок оценки: Until expected number of events are adjudicated 3 years]
• iSTEMI (IVUS) [Срок оценки: Until expected number of events are adjudicated 3 years]
• iSTEMI (IVUS) [Срок оценки: Until expected number of events are adjudicated 3 years]
• iSTEMI (IVUS) [Срок оценки: Until expected number of events are adjudicated 3 years]
• iSTEMI (IVUS) [Срок оценки: Until expected number of events are adjudicated 3 years]
• iSTEMI (IVUS) [Срок оценки: Until expected number of events are adjudicated 3 years]
• iPOST [Срок оценки: Until expected number of events are adjudicated 3 years]
• iPOST [Срок оценки: Until expected number of events are adjudicated 3 years]
• iPOST [Срок оценки: Until expected number of events are adjudicated 3 years]
• iPOST [Срок оценки: Until expected number of events are adjudicated 3 years]
• iPOST [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age ≥18 years
• Acute onset of chest pain with <12 hours duration
• STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior AMI.

Exclusion Criteria (iPOST2):

Pre-PCI TIMI flow 0 or 1 Potential pregnancy Inability to provide informed consent Unwillingness to consent Unavoidable to use thrombectomy Spontaneous coronary artery dissection Time from symptoms onset to PPCI > 12 hours Culprit in bypass graft Other reason for not including the patient

Exclusion Criteria (iSTEMI):

Potential pregnancy Inability to understand information in order to provide informed consent Unwillingness to consent Spontaneous coronary artery dissection Time from symptoms inset to PPCI > 12 hours Culprit in bypass graft Other reason

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Heart Center, Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT04775914 · H-18051256b

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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