Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT04239495
Eligibility Criteria:
Inclusion Criteria:
Primary care source:
\- Registered patient with one of the GP (General Practice) surgeries identified as PIC (Participant Identification Centre) via North East and North Cumbria Clinical Research Network.
Secondary care source:
\- Attending a NuTH (Newcastle upon Tyne Hospitals NHS Foundation Trust) clinical area.
NIHR Bioresource:
\- Participants identified by the NIHR Bioresource Centre Newcastle as being eligible for the study and who have not previously expressed a wish to no longer be contacted about further studies.
For all recruitment sources:
* Has capacity to consent.
* Within the study age range (45-85 years).
* Not taking any anticoagulant or antiplatelet medications (see below under exclusion criteria), with the exception of aspirin being taken for primary prevention (i.e. where there is no diagnosis of cardiovascular disease).
Exclusion Criteria:
\- Inability to give informed consent.
\- As the study involves biopsy of skeletal muscle, individuals who are taking medications that increase bleeding risk are excluded, specifically: i. anti-coagulant medication: warfarin, injected low-molecular weight heparins such as dalteparin, and direct oral anticoagulant drugs such as rivaroxaban and apixaban.
ii. anti-platelet medication such as clopidogrel or prasugrel. This also includes aspirin where an individual has a known history of cardiovascular disease. Aspirin being taken where there is no history of cardiovascular disease is acceptable, as we would consider there to be minimal risk of stopping the aspirin for 14 days prior to biopsies.
* Individuals known to have diabetes mellitus, due to the increased risk of infection at the biopsy sites.
* Individuals currently taking medication that suppresses the immune system (such as prednisolone or methotrexate), due to the increased risk of infection or poor healing of the biopsy sites.
* Pregnancy, due to the exposure to small amount of ionising radiation during the DXA scan.
* Individuals who use a wheelchair or who are unable to walk without assistance, as we would anticipate that the muscle biopsy procedure would not be feasible in these groups.
* An individual who the NuTH clinician / GP feels it is inappropriate for the researchers to approach - the NuTH clinician / GP may consider an individual unsuitable for approach for reasons such as end stage terminal disease or safety risk.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT04239495
Study Brief:
Protocol Section:
NCT04239495