CRP Apheresis in Infarct-Related Cardiogenic Shock

Официальное название

Selective C-Reactive Protein Apheresis in Cardiogenic Shock Complicating Acute Myocardial Infarction (CRP-SHOCK Trial)

Обзор

Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction. The CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system. The primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.

Подробное описание

Cardiogenic shock following acute myocardial infarction is associated with a high inflammatory response and mortality rates of approximately 40-50% despite early revascularization and intensive care treatment. Experimental and clinical evidence suggests that elevated C-reactive protein (CRP) contributes to myocardial injury, impaired tissue regeneration, and adverse outcomes.

The CRP-SHOCK trial investigates whether selective removal of circulating CRP by apheresis improves short-term risk stratification and clinical outcomes in patients with infarct-related cardiogenic shock. The intervention consists of up to three CRP apheresis sessions initiated within 5 ± 1 hours after randomization and repeated at predefined intervals using the PentraSorb®-CRP system.

The primary efficacy endpoint is the CLIP score at 66 ± 8 hours after randomization. Secondary endpoints include mortality, major adverse cardiovascular events, biomarkers of inflammation and organ function, and safety outcomes such as bleeding, stroke, and infections. The trial is conducted as a multicenter pilot study in Germany and Austria.

Вмешательства

• Устройство Selective C-reactive protein apheresis (PentraSorb®-CRP)
  Selective removal of circulating C-reactive protein using the PentraSorb®-CRP adsorber system as an adjunct to guideline-directed standard of care.
• Другое Standard of care
  Guideline-directed medical and interventional treatment for cardiogenic shock complicating acute myocardial infarction.

Первичные конечные точки

• CLIP score [Срок оценки: 66 ± 8 hours after randomization]

Вторичные конечные точки (12)

• Major adverse cardiovascular events (MACE) [Срок оценки: 30 days]
• All-cause mortality [Срок оценки: 30 days]
• Cardiovascular mortality [Срок оценки: 30 days]
• CLIP score over time [Срок оценки: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization]
• Individual components of the CLIP score [Срок оценки: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization]
• C-reactive protein (CRP) concentration [Срок оценки: 9 ± 1 hours, 34 ± 4 hours, 58 ± 6 hours, and 66 ± 8 hours after randomization]
• Peak NT-proBNP concentration [Срок оценки: During index hospitalization]
• Peak serum creatinine concentration [Срок оценки: During index hospitalization]
• Cardiac power index [Срок оценки: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization]
• Time to hemodynamic stabilization [Срок оценки: hospital discharge]
• Duration of catecholamine therapy [Срок оценки: hospital discharge]
• Length of intensive care unit stay [Срок оценки: hospital discharge]

Критерии участия

Критерии включения

• Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).
• Cardiogenic shock defined as:
• Systolic blood pressure <90 mmHg for >30 minutes or requirement of catecholamine infusion to maintain systolic blood pressure ≥90 mmHg, and
• Signs of impaired organ perfusion (at least one of the following): Cold, clammy skin and extremities, Altered mental status, Oliguria with urine output <30 mL/hour, Arterial lactate >2 mmol/L
• C-reactive protein (CRP) level ≥7 mg/L at baseline.
• Age ≥18 years.
• Informed consent provided by the participant or, if the participant is unable to consent, inclusion after assessment and documentation of the presumed patient's will by two physicians (one independent), with informed consent obtained as soon as possible.

Критерии исключения

• Fever (body temperature >38°C) or acute infection with fever within the last 14 days.
• Chronic inflammatory disease.
• Known history of severe hepatic failure.
• Chronic kidney disease with creatinine clearance <30 mL/min/1.73 m² prior to hospital admission.
• Life expectancy <12 months prior to cardiogenic shock.
• Participation in another interventional clinical trial.
• Pregnancy.
• Resuscitation duration >30 minutes.
• Cardiogenic shock due to causes other than acute myocardial infarction.
• Onset of cardiogenic shock >12 hours before randomization.
• Age >80 years.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Heart Center Leipzig at University of Leipzig — Leipzig

Публикации

• Pöss J, Köster J, Fuernau G, et al. Risk stratification for patients in cardiogenic shock after acute myocardial infarction. European Heart Journal. 2017;38:386-396.
• Slagman A, Searle J, Müller C, et al. C-reactive protein apheresis in acute myocardial infarction: results of the CAMI-1 study. Clinical Research in Cardiology. 2021;110:1597-1606.
• Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 201 PMID 22920912
• Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myo PMID 29083953

Идентификаторы

NCT: NCT07687017 · CRP-SHOCK Trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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