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NCT03962309: SKIM
Selection of People at Low Cardiovascular Risk: Development of an Inexpensive Pre-screening Algorithm Using Only Non-laboratory Measures. The SKIM Risk Study.
trial testing Health self-assessment questionnaire in Epidemiology of Cardiovascular Risk in 2,699 participants. Completed in 31 August 2024.
30 June 2024
Quick facts
| Lead sponsor | Mario Negri Institute for Pharmacological Research |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 2,699 |
| Start date | 18 December 2020 |
| Primary completion | 30 June 2024 |
| Estimated completion | 31 August 2024 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- Health self-assessment questionnaire
Conditions studied
- Epidemiology of Cardiovascular Risk — all drugs for Epidemiology of Cardiovascular Risk →
Sponsor
Mario Negri Institute for Pharmacological Research
Who can join
Adults 40 to 69, any sex, with Epidemiology of Cardiovascular Risk. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Early identification of individuals at high risk remains the cornerstone of primary cardiovascular prevention (CV). However, cardiovascular screening including people at low CV diseases (CVD) risk are too costly, time consuming and poorly effective in reducing incident CV events to be proposed at population level. Thus, innovative tools that allow to exclude low risk subjects in order to concentrate the relatively poor resources of NHS for primary prevention in high risk groups are needed. In this study, we will assess whether a new low cost strategy for CV risk stratification, based on non-laboratory measures, will allow to recognize low risk subjects who do not need further and expensive measures. To this end, we will take advantage of a General Practitioners (GPs) national network that will allow to work in the natural contest of primary prevention. If successful, the project will provide the basis for future, cost-effective prevention programs to be performed at national level.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03962309
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03962309 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mario Negri Institute for Pharmacological Research
- Last refreshed: 7 May 2025
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing