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A proof of concept study to identify familial hypercholesterolaemia in primary care

A proof of concept study to identify familial hypercholesterolaemia (FH) among 18 - 40 year old patients presenting in a primary care setting

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000153516
Acronym
POCT
Enrollment
199
Registered
2015-02-17
Start date
2015-05-04
Completion date
2015-10-27
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Familial Hypercholesterolaemia (FH) is an inherited condition which results in excessively high levels of cholesterol in the bloodstream from birth, with increased risk of heart problems by age 40 or earlier if not treated. Early diagnosis and treatment are very effective and reduces long-term disease costs. This study examines the feasibility of employing a new method of detecting FH through GP clinics using a finger prick cholesterol blood test. If FH is diagnosed, close relatives will also be checked so early treatment can be offered. This proposed innovative approach will alleviate hospital load and allow FH to be managed by the patient’s GP and lipid specialist in shared care approach

Interventions

This is a proof of concept study: Recruitment of patients will take place over 5 months. Patients presenting to general practitioner (GP) will be invited to participate. Upon consent GP or practice nurse (PN) will undertake a non-fasting finger prick test using the Cardiocheck PA analyser to measure patient's LDL-c level. If level is above 4.9mmol/L, a fasting lipid blood test will be carried out to confirm the results. If a level above 4.9mmol/L is maintained, patient will be recalled and as

This is a proof of concept study: Recruitment of patients will take place over 5 months. Patients presenting to general practitioner (GP) will be invited to participate. Upon consent GP or practice nurse (PN) will undertake a non-fasting finger prick test using the Cardiocheck PA analyser to measure patient's LDL-c level. If level is above 4.9mmol/L, a fasting lipid blood test will be carried out to confirm the results. If a level above 4.9mmol/L is maintained, patient will be recalled and assessed using the Dutch Lipid Clinic Network Score (DLCNS) for FH. Patients with a score under or equal to 5 will be classed as low complexity FH and managed at the discretion of the GP. Patients with a score above 5 will be referred for FH in a shared care model between GP and specialist. As part of clinical care, first degree relatives will also be offered further investigations for FH.

Sponsors

Prof Tom Brett
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

patients, 18 - 40 years of age, who are presenting to their GP for any consultation.

Exclusion criteria

Less than 18 or more than 40 years of age

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026