- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03980548
Targeting Mitochondrial Fusion and Fission to Prevent Atherosclerosis: Getting the Balance Right (MITOFFA)
Targeting Mitochondrial Fusion and Fission to Prevent Atherosclerosis: Getting the Balance Right - MITOFFA
Panoramica dello studio
Descrizione dettagliata
Study 1 (tissue sample study): To investigate the changes in mitochondrial function and pro-inflammatory markers in human arterial atherosclerotic plaques.
Hypothesis: Macrophages from femoral artery atherosclerotic plaques in patients with peripheral artery disease will display upregulation of mitochondrial fission proteins and features of pro-inflammatory activation.
Study 2 (white blood cell study): To investigate the changes in mitochondrial function and pro-inflammatory markers in white blood cells from patients with stable and unstable coronary artery didease (CAD).
Hypothesis: Monocytes from patients with unstable CAD will display upregulation of Drp1 and features of pro-inflammatory activation, mitochondrial fission, impaired mitochondrial respiratory function, and perturbed metabolism, when compared to monocytes from patients with stable CAD.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Singapore, Singapore, 169609
- Reclutamento
- Hector A. Cabrera-Fuentes
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Contatto:
- Tan Mui Teng
- Numero di telefono: 67042297
- Email: tan.mui.teng@nhcs.com.sg
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Study 1 (tissue sample study):
- 25 adult patients undergoing coronary artery bypass graft (CABG) surgery: Control tissue will be collected from the left internal mammary artery (LIMA) or radial artery (RA) Atherosclerotic tissue will be collected from aortic root
- 25 adult patients undergoing surgical femoral or carotid endarterectomy Endarterectomy atherosclerotic tissue will be collected
Study 2 (white blood cell study):
- 50 healthy adult volunteers Control blood sample will be collected
- 50 adult patients with stable CAD Stable CAD blood sample will be collected
- 50 adult patients with unstable CAD Unstable CAD blood sample will be collected
Descrizione
Inclusion Criteria:
Study 1 (tissue sample study):
CABG patients
- Patients aged ≥21 years old
- Undergoing elective CABG with aortic valve surgery
PAD patients:
- Patients aged ≥21 years old
- Undergoing either elective surgical femoral or carotid endarterectomy
Study 2 (white blood cell study):
1) Healthy volunteers aged ≥21 years old 2) Patients with stable CAD 3) Patients admitted with ACS treated by PCI in prior 24 hours.
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Exclusion Criteria:
- General exclusion criteria will be a known history of leucopenia, thrombocytopenia, or severe hepatic or renal dysfunction, as well as evidence for inflammatory or malignant disease.
- History of haematological disorders
- Cardiac arrest, Cardiogenic shock, Poor pre-morbid status, Pregnancy
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Volontari sani
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Altri nomi:
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CABG patients
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Altri nomi:
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PAD patients
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Altri nomi:
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Patients with CAD
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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"mitochondria-shaping" proteins expression quantified on immunoblotting in patients with atherosclerosis disease.
Lasso di tempo: 2 years
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Primary outcome analysis for aim 1: The primary endpoint is "mitochondria-shaping" proteins expression quantified on immunoblotting in patients with atherosclerosis disease. The statistical analysis will be performed by 2-tailed student's T-test with the platelet "mitochondria-shaping" proteins expression as the response variable. The primary analyses will be by per protocol analysis and there will also be an intention to treat analysis. Primary outcome analysis for aim 1: The primary endpoint is "mitochondria-shaping" proteins expression quantified on immunoblotting in patients with atherosclerosis disease. The statistical analysis will be performed by 2-tailed student's T-test with the platelet "mitochondria-shaping" proteins expression as the response variable. The primary analyses will be by per protocol analysis and there will also be an intention to treat analysis. The primary endpoint is "mitochondria-shaping" proteins expression quantified on immunoblotting in patients |
2 years
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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2018/2497
- SHF/FG651P/2017 (Altro numero di sovvenzione/finanziamento: SingHealth Foundation)
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .