Investigating the role of salt inducible kinases in atherosclerosis

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Recruitment status:
Recruiting
Primary Sponsor:
NHS Tayside/University of Dundee
Recruitment countries:
United Kingdom
Health condition studied:
STEMI, peripheral arterial disease
Circulatory System
URL:
Link to the clinical trial website

About the trial

Interventions:
Three groups will be evaluated in this study:

Group 1. 10 patients with peripheral vascular disease (PVD) undergoing elective amputation. These patients will undergo blood sampling and amputated tissue analysis.

Group 2. 40 patients with acute myocardial infarction with ST elevation (STEMI) and requiring primary percutaneous coronary intervention (PPCI). These patients will undergo blood samples, flow mediated dilatation (FMD) and arterial stiffness measurements.

Group 3. 40 healthy subjects, matched to the STEMI group for age and gender. They will undergo blood samples, flow-mediated dilatation and pulse wave analysis.
Key inclusion and exclusion criteria:
  • Inclusion criteria: PVD:
    1. Age between 18-70 years
    2. Admitted for elective amputation for PVD
    3. Able to give written informed consent

    STEMI:
    4. Age between 18-70 years
    5. Admitted to CCU for STEMI and undergone PPCI
    6. Able to give written informed consent

    Healthy volunteers:
    7. Age between 18-70 years
    8. No current or previous significant medical illness
    9. Able to give written informed consent
  • Exclusion criteria: Healthy volunteers:
    1. Positive medical history of:
    1.1. Vascular diseases such as peripheral arterial disease, stroke, IHD... etc
    1.2. Haematological conditions such as hypercoagulability, deep venous thrombosis... etc
    1.3. Hypertension
    2. Alcohol excess
    3. Unable to give written informed consent

    STEMI/PVD:
    Unable to give written informed consent
  • Age minimum: 
  • Age maximum: 
  • Gender:  Both
Primary outcomes:
Serum levels of inflammatory cytokines taken at the time of operation in PVD group, 48-72 hours after PCI in STEMI group and at the time of assessment in healthy volunteers.
Secondary outcomes:
1. Tissue SIK levels in PVD patients at the time of surgery
2. Arterial stiffness and flow mediated dilatation in STEMI patients at 48-72 hours and in healthy volunteers at the time of assessment
Target sample size:
90
Study type:
Observational
Study design:
Observational cross-sectional study (Diagnostic)
Contacts:
  • Name:  
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation: 
  • Name: Faisel Khan
  • Address:  Division of Cardiovascular and Diabetes Medicine Mailbox 1 Ninewells Hospital and Medical School
  • Phone:  01382 383531
  • Email:  f.khan@dundee.ac.uk
  • Affiliation: 

Technical details

Scientific title:
Investigating the role of salt inducible kinases in atherosclerosis: a observational cross-sectional study
Sources of monetary support:
Tenovus
Secondary sponsors:
Main ID:
ISRCTN14632677
Secondary ID:
2015CV11
Register:
ISRCTN
Date of registration:
28/06/2016
Date of first enrollment:
01/08/2016
Last refreshed:
27 February 2017

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