- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Singapore, Singapore, 169609
- Rekruttering
- Hector A. Cabrera-Fuentes
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Kontakt:
- Tan Mui Teng
- Telefonnummer: 67042297
- E-mail: tan.mui.teng@nhcs.com.sg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Sunde frivillige
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Andre navne:
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CABG patients
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Andre navne:
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PAD patients
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Andre navne:
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Patients with CAD
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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"mitochondria-shaping" proteins expression quantified on immunoblotting in patients with atherosclerosis disease.
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018/2497
- SHF/FG651P/2017 (Andet bevillings-/finansieringsnummer: SingHealth Foundation)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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