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Role of Red Blood Cells in Cardiovascular Disease

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT07151222 es un ensayo observacional para Diabetes mellitus. Su estado actual es: reclutando. El ensayo se inició el 1 de enero de 2017, con el objetivo de reclutar a 500 participantes. Dirigido por el Instituto Karolinska, se espera que finalice el 30 de diciembre de 2031. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de septiembre de 2025.
Resumen
The risk of myocardial infarction is dependent on cardiovascular risk factors including type 2 diabetes (T2D) but underlying mechanisms are poorly understood. We identified that red blood cells (RBCs) mediate beneficial cardiovascular regulatory effects under hypoxic/ischemic conditions via signaling by nitric oxide (NO) and soluble guanylate cyclase (sGC) in the RBCs. The RBCs become dysregulated in T2D which induces endothelial and cardiac injury. This project investigates the signaling of RBCs in cardiovascular disease and explores novel therapeutic strategies that target RBC function in myocardial infarction and T2D.

Aims To determine the

  • mechanisms behind cardioprotective effect of RBCs in myocardial infarction
  • signaling behind cardiovascular injury induced by RBCs in T2D

Work plan RBCs collected from patients with myocardial infarction, patients with T2D and healthy controls are investigated in bioassays including isolated hearts of ischemia/reperfusion, endothelial function and cell cultures. Molecular mechanisms behind the effects of RBCs are identified with focus on the NO-sGC pathway in the RBCs.

This project unravels the RBC as a mediator of cardiovascular disease and has the potential to identify novel therapeutic strategies by targeting RBC signaling.

Descripción detallada
The function of RBCs are investigated in functional bioassays and cell culture systems. The bioassays include isolated hearts subjected to ischemia-reperfusion and isolated arteries. the readouts are left ventricular function, infarct size and endothelial function . Comparisons are made between RBCs collected from patients with cardiovascular disease, type 2 diabetes and healthy controls. Pharmacological interventions are performed by ex vivo incubations with focus on the NO-sGC pathway.
Título oficial

The Red Blood Cell as a Mediator and Therapeutic Target in Cardiovascular Disease

Condiciones médicas
Diabetes mellitus
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este ensayo clínico:
Otros ID del ensayo
  • 2024-02534
Número del NCT
NCT07151222
Inicio del ensayo (real)
2017-01-01
Última actualización
2025-09-03
Fecha de finalización (estimada)
2031-12-30
Inscripción (prevista)
500
Tipo de estudio
Observacional
Estado general
Reclutando
Palabras clave
Red blood cells
Nitric oxide
diabetes
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Type 2 diabetes
Patients with type 2 diabetes
N/A
Type 1 diabetes
Patients with type 1 diabetes
N/A
Coronary artery disease/Myocardial infarction
Patients with acute coronary syndromes
N/A
Healthy controls
Age- and gender-matched healthy subjects
N/A
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Red blood cell function defined as their ability to modulated post-ischemic recovery of left ventricular developed pressure, myocardial infarct size and endothelium-dependent relaxation.
The function of red blood cells (RBCs) are investigated in isolated heart preparations and in isolated aorta. The heart preparations are subjected to ischemia followed by 60 min reperfusion and RBCs are administered into the coronary circulation at the onset of ischemia. Left ventricular developed pressure is recorded as readout of left ventricular function. Final infarct size is determined at the end of the reperfusion period. Isolated arteries are co-incubated with the RBCs for 18 h. Following the incubation, the arteries are mounted in myographs for the determination of endothelium-dependent and endothelium-independent relaxations.
At 60 min of reperfusion
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Red blood cell production of reactive oxygen species
Red blood cell (RBC) production of reactive oxygen species (ROS) is determined at baseline and following incubation of the RBCs with pharmacological tools that modulate different sources of ROS formation. These include nitric oxide synthase inhibitors, NADPH-oxidase inhibitors, arginase inhibitors.
At baseline and following ex vivo inhibition of ROS formation.
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
25 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
  • Type 2 diabetes

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Karolinska Institutet logoInstituto Karolinska
Karolinska University Hospital logoKarolinska University Hospital
Parte responsable del ensayo
John Pernow, Investigador principal, Professor, Karolinska Institutet
Contactos centrales del ensayo
Contacto: John Pernow, MD, +46704848361, [email protected]
1 Sitios del ensayo en 1 países

Swsden

Karolinska Institutet, Stockholm, Swsden, 17176, Sweden
Stina Smetana, Nurse, Contacto, +46 725841182, [email protected]
Reclutando