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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06304415
Other study ID # CIRB2023/2651
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date December 31, 2036

Study information

Verified date March 2024
Source Changi General Hospital
Contact Clinical Trials & Research Unit
Phone 64267818
Email ctru@cgh.com.sg
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The objective of this study is to investigate the prevalence of elevated Lp(a) in the working general population.


Description:

The objective of this study is to investigate the prevalence of elevated lipoprotein(a) concentrations and distribution of lipoprotein(a) in a working general population. This is a prospective study investigating the association of lipoprotein(a) with cardiovascular markers and outcomes.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2800
Est. completion date December 31, 2036
Est. primary completion date December 1, 2035
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 100 Years
Eligibility Inclusion Criteria: Any hospital staff aged 21 and above. Family members of index cases of high elevated lipoprotein(a) can also participate in this study Exclusion Criteria: - Inability to provide informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Singapore Clinical Trials & Research Unit Singapore

Sponsors (1)

Lead Sponsor Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (5)

Kronenberg F, Mora S, Stroes ESG, Ference BA, Arsenault BJ, Berglund L, Dweck MR, Koschinsky M, Lambert G, Mach F, McNeal CJ, Moriarty PM, Natarajan P, Nordestgaard BG, Parhofer KG, Virani SS, von Eckardstein A, Watts GF, Stock JK, Ray KK, Tokgozoglu LS, Catapano AL. Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement. Eur Heart J. 2022 Oct 14;43(39):3925-3946. doi: 10.1093/eurheartj/ehac361. — View Citation

Loh WJ, Chan DC, Mata P, Watts GF. Familial Hypercholesterolemia and Elevated Lipoprotein(a): Cascade Testing and Other Implications for Contextual Models of Care. Front Genet. 2022 Apr 27;13:905941. doi: 10.3389/fgene.2022.905941. eCollection 2022. — View Citation

Loh WJ, Chang X, Aw TC, Phua SK, Low AF, Chan MY, Watts GF, Heng CK. Lipoprotein(a) as predictor of coronary artery disease and myocardial infarction in a multi-ethnic Asian population. Atherosclerosis. 2022 May;349:160-165. doi: 10.1016/j.atherosclerosis.2021.11.018. Epub 2021 Nov 26. — View Citation

Loh WJ, Watts GF. Detection strategies for elevated lipoprotein(a): will implementation let the genie out of the bottle? Curr Opin Endocrinol Diabetes Obes. 2023 Apr 1;30(2):94-102. doi: 10.1097/MED.0000000000000789. Epub 2022 Dec 5. — View Citation

Nestel P, Loh WJ, Ward NC, Watts GF. New Horizons: Revival of Lipoprotein (a) as a Risk Factor for Cardiovascular Disease. J Clin Endocrinol Metab. 2022 Nov 23;107(11):e4281-e4294. doi: 10.1210/clinem/dgac541. Erratum In: J Clin Endocrinol Metab. 2022 Oct 20;: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Distribution and prevalence of elevated Lipoprotein(a) Investigate the distribution lipoprotein(a) and prevalence of elevated lipoprotein(a) concentrations in various ethnicities. 3 years
Secondary Correlation of lipoprotein(a) with cardiovascular outcomes Observational study to assess the correlation of degree of elevation of lipoprotein(a) with cardiovascular outcomes prospectively. 10 years
Secondary Genetic variants of lipoprotein(a) and cardiovascular outcomes atherosclerotic events Assess the association of genetic variants of lipoprotein(a) with the measured lipoprotein(a) concentrations in various ethnicities, and prospectively assess the association of these genetic variants with cardiovascular outcomes 10 years
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