- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02373319
Self-screening of Cardiovascular Risk (ACRISC)
Validity and Effectiveness of a Method for Self-screening of Cardiovascular Risk
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Primary prevention activities based on some admittedly blunt screening instruments such as cardiovascular (CV) risk functions must be addressed to the whole population, prioritizing certain sectors of the population. However, the main limitation of current risk screening procedures is related to the natural history of cardiovascular disease, whose expression depends on the cumulative exposure to cardiovascular risk factors throughout a person's lifetime. Early prevention of cardiovascular disease is key to reduce this cumulative risk, thereby reducing the incidence of cardiovascular events.
The objectives of this study are (1) to validate a self-screening method for cardiovascular risk that does not require the supervision of a health professional (including self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) From these data, the investigators will generate personalized recommendations based on the best available evidence. The investigators will also analyze whether this innovative approach improves adherence to preventive recommendations for cardiovascular and other chronic diseases.
Cardiovascular risk measured with the self-screening method will be compared with the gold standard (cardiovascular risk supervised by health professional). Participants will be randomly assigned to the intervention (communication of cardiovascular risk and recommendation of personalized preventive actions) or control groups (communication of cardiovascular risk). Subjects will be reexamined one year after recruitment for assessing adherence to the preventive recommendations in terms of improvement in the control of cardiovascular risk factors.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Girona, Spania, 17002
- Unitat de Suport a la Recerca de Girona IDIAP Jordi Gol
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Understand and accept the study's procedures and sign an informed consent form
- Inhabitants of Girona (Gerona, Spain) and the metropolitan area
Exclusion Criteria:
- History of cardiovascular disease
- Individuals with terminal disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: CV-screening-1 plus personalized
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
|
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
|
Eksperimentell: CV-screening-2 plus personalized
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
|
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
|
Aktiv komparator: CV-screening-1 plus standard
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Standard communication of the health exam results
|
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Standard communication of the health exam results
|
Aktiv komparator: CV-screening-2 plus standard
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results
|
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pre-post changes in blood lipid levels
Tidsramme: [Time frame: From baseline to 12 months after the intervention]
|
Pre-post changes in mean levels of blood lipid levels (total, HDL and LDL cholesterol).
Blood samples will be obtained at baseline and 12 months after the intervention.
|
[Time frame: From baseline to 12 months after the intervention]
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pre-post changes in controlled blood lipid levels
Tidsramme: From baseline to 12 months after the intervention
|
Pre-post changes in the percentage of individuals with controlled blood lipid levels according to the most updated European Clinical Practice Guidelines (total, HDL and LDL cholesterol).
Blood samples will be obtained at baseline and 12 months after the intervention.
|
From baseline to 12 months after the intervention
|
Pre-post changes in controlled blood pressure
Tidsramme: From baseline to 12 months after the intervention
|
Pre-post changes in the percentage of individuals with controlled systolic and diastolic blood pressure levels (140 and 90 mmHg, respectively).
Measures will be obtained at baseline and 12 months after the intervention
|
From baseline to 12 months after the intervention
|
Pre-post changes in controlled body mass index
Tidsramme: From baseline to 12 months after the intervention
|
Pre-post changes in the percentage of individuals with body mass index below 25 kg/m2.
Measures will be obtained at baseline and 12 months after the intervention.
|
From baseline to 12 months after the intervention
|
Pre-post differences in smoking status
Tidsramme: From baseline to 12 months after the intervention
|
Pre-post changes in the percentage of smokers.
Smoking status will be assessed at baseline and 12 months after the intervention
|
From baseline to 12 months after the intervention
|
Mean difference between two methods of cardiovascular risk estimation
Tidsramme: From baseline to 30 minutes
|
Comparison of cardiovascular risk estimates by two methods (Screening of cardiovascular risk supervised by health professional (Gold Standard) - self-screening of cardiovascular risk).
Measures with each method will be taken 30 minutes apart after a wash-out period
|
From baseline to 30 minutes
|
Pre-post changes in blood pressure
Tidsramme: From baseline to 12 months after the intervention
|
Pre-post changes in mean levels of systolic and diastolic blood pressure.
Measures will be obtained at baseline and 12 months after the intervention.
|
From baseline to 12 months after the intervention
|
Pre-post changes in body mass index
Tidsramme: From baseline to 12 months after the intervention
|
Pre-post changes in mean levels of systolic and diastolic blood pressure.
Measures will be obtained at baseline and 12 months after the intervention.
|
From baseline to 12 months after the intervention
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Maria Grau, MD, PhD, MPH, IMIM
- Studieleder: Jaume Marrugat, MD, PhD, IMIM
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Asumi M, Sugawara A, Totsuka K, Shimano H, Ohashi Y, Yamada N, Sone H. Cardiorespiratory fitness as a quantitative predictor of all-cause mortality and cardiovascular events in healthy men and women: a meta-analysis. JAMA. 2009 May 20;301(19):2024-35. doi: 10.1001/jama.2009.681.
- Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.
- Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
- Marrugat J, Subirana I, Comin E, Cabezas C, Vila J, Elosua R, Nam BH, Ramos R, Sala J, Solanas P, Cordon F, Gene-Badia J, D'Agostino RB; VERIFICA Investigators. Validity of an adaptation of the Framingham cardiovascular risk function: the VERIFICA Study. J Epidemiol Community Health. 2007 Jan;61(1):40-7. doi: 10.1136/jech.2005.038505. Erratum In: J Epidemiol Community Health. 2007 Jul;61(7):655.
- Grau M, Subirana I, Elosua R, Solanas P, Ramos R, Masia R, Cordon F, Sala J, Juvinya D, Cerezo C, Fito M, Vila J, Covas MI, Marrugat J. Trends in cardiovascular risk factor prevalence (1995-2000-2005) in northeastern Spain. Eur J Cardiovasc Prev Rehabil. 2007 Oct;14(5):653-9. doi: 10.1097/HJR.0b013e3281764429. Erratum In: Eur J Cardiovasc Prev Rehabil. 2008 Aug;15(4):502.
- Kahn R, Robertson RM, Smith R, Eddy D. The impact of prevention on reducing the burden of cardiovascular disease. Circulation. 2008 Jul 29;118(5):576-85. doi: 10.1161/CIRCULATIONAHA.108.190186. Epub 2008 Jul 7.
- Barroso M, Zomeno MD, Diaz JL, Perez S, Marti-Lluch R, Cordon F, Ramos R, Cabezas C, Salvador G, Castell C, Schroder H, Grau M. Efficacy of tailored recommendations to promote healthy lifestyles: a post hoc analysis of a randomized controlled trial. Transl Behav Med. 2021 Aug 13;11(8):1548-1557. doi: 10.1093/tbm/ibab035.
- Barroso M, Perez-Fernandez S, Vila MM, Zomeno MD, Marti-Lluch R, Cordon F, Ramos R, Elosua R, Degano IR, Fito M, Cabezas C, Salvador G, Castell C, Grau M. Validity of a method for the self-screening of cardiovascular risk. Clin Epidemiol. 2018 May 10;10:549-560. doi: 10.2147/CLEP.S158358. eCollection 2018.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 5815/I
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