NCT03934320: FAMCAT

Improving Identification of Familial Hypercholesterolaemia in Primary Care (FAMCAT)

Status unknown NA Last updated 1 May 2019

What this trial tests

NA trial testing FAMCAT in Familial Hypercholesterolemia in 400 participants. Status unknown.

Timeline

12 June 2017

Primary endpoint
31 July 2020

31 July 2020

Quick facts

Lead sponsor	University of Nottingham
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	400
Start date	12 June 2017
Primary completion	31 July 2020
Estimated completion	31 July 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• FAMCAT

Conditions studied

• Familial Hypercholesterolemia — all drugs for Familial Hypercholesterolemia →

Sponsor

University of Nottingham

Who can join

18 and older, any sex, with Familial Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multi-centre, non-randomised, non-controlled quasi-experimental study with nested qualitative study and economic appraisal.

Improving the identification of patients at high risk of cardiovascular disease in primary care, caused by conditions such as familial hypercholesterolaemia (FH), is a well-recognised national priority to prevent morbidity and mortality by early effective intervention.

This study will prospectively evaluate the clinical utility of the new primary care FH identification tool (FAMCAT) for identifying undiagnosed FH in routine primary care practice; and to assess its appropriateness, acceptability and cost-effectiveness.

This study will answer the following research questions (RQ):

1. What is the detection rate for new genetically-confirmed FH cases using the FAMCAT algorithm?
2. Is the FAMCAT tool appropriate and acceptable to practitioners and patients?
3. How can the FAMCAT tool be optimised to improve identification of FH?
4. What is the potential cost-effectiveness of the FAMCAT tool compared with current practice to identify patients with FH?
5. Can the FAMCAT intervention be improved?
6. What definitive study design and outcome measures are needed to provide robust evidence on whether to introduce FAMCAT into primary care practice?

RQ(1) \& (3) will be answered by a quasi-experimental diagnostic accuracy study; RQ(2) \& (5) answered by qualitative study; RQ (4) answered by economic appraisal and RQ(6) informed by all previous studies.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Case-finding and genetic testing for familial hypercholesterolaemia in primary care.
   Qureshi N, Akyea RK, Dutton B, Humphries SE, et al · · 2021 · cited 13× · PMID 34521694 · DOI 10.1136/heartjnl-2021-319742
2. Comparing the performance of the novel FAMCAT algorithms and established case-finding criteria for familial hypercholesterolaemia in primary care.
   Qureshi N, Akyea RK, Dutton B, Leonardi-Bee J, et al · · 2021 · cited 12× · PMID 34635577 · DOI 10.1136/openhrt-2021-001752