- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Singapore, Singapore, 169609
- Rekrytering
- Hector A. Cabrera-Fuentes
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Kontakt:
- Tan Mui Teng
- Telefonnummer: 67042297
- E-post: tan.mui.teng@nhcs.com.sg
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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Friska volontärer
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Andra namn:
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CABG patients
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Andra namn:
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PAD patients
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Andra namn:
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Patients with CAD
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Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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"mitochondria-shaping" proteins expression quantified on immunoblotting in patients with atherosclerosis disease.
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2018/2497
- SHF/FG651P/2017 (Annat bidrag/finansieringsnummer: SingHealth Foundation)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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