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O estudo clínico NCT07151222 para Diabetes mellitus está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Role of Red Blood Cells in Cardiovascular Disease

Recrutando
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O estudo clínico NCT07151222 é um ensaio observacional para Diabetes mellitus. Seu status atual é: recrutando. O estudo começou em 1 de janeiro de 2017 e pretende incluir 500 participantes. Coordenado por o Instituto Karolinska e deve ser concluído em 30 de dezembro de 2031. Essas informações foram atualizadas no ClinicalTrials.gov em 3 de setembro de 2025.
Resumo
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.

Descrição detalhada
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

Condições
Diabetes mellitus
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
Outros IDs do estudo
  • 2024-02534
Número NCT
NCT07151222
Data de início (real)
2017-01-01
Última atualização postada
2025-09-03
Data de conclusão (estimada)
2031-12-30
Inscrição (estimada)
500
Tipo de estudo
Observacional
Status
Recrutando
Palavras-chave
Red blood cells
Nitric oxide
diabetes
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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.
Critérios de elegibilidade

Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
25 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
  • Type 2 diabetes

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Karolinska Institutet logoInstituto Karolinska
Karolinska University Hospital logoKarolinska University Hospital
Responsável pelo estudo
John Pernow, Investigador principal, Professor, Karolinska Institutet
Contato central do estudo
Contato: John Pernow, MD, +46704848361, [email protected]
1 Locais do estudo em 1 países

Swsden

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