Comparison of Vascular Age Changes Over Two Time Periods Between Clinical Trial Participants and Patients Receiving Routine Outpatient Care

Authors

DOI:

https://doi.org/10.59471/ijhsc2026426

Keywords:

Age, Cardiovascular Risk Assessment, Clinical Trials, Cardiovascular Prevention, Risk Factor Control, Patient Follow-Up, Treatment Adherence

Abstract

Introduction: Participation in clinical trials may contribute to improved cardiovascular risk factor control through structured follow-up, greater adherence to therapeutic recommendations, and closer clinical monitoring. Objective: To compare changes in the difference between vascular age and chronological age among patients enrolled in clinical research protocols and patients receiving routine outpatient care. Methods: A retrospective observational study was performed in 75 patients followed for 24 months. The primary outcome was the change in the vascular age–chronological age difference (vascular age delta). Comparisons between groups were performed using adjusted statistical models considering relevant clinical variables. Results: Patients participating in clinical protocols showed a greater reduction in vascular age delta compared with those receiving routine care (4.5% vs. 1.4%). The adjusted difference between groups was 3.1 percentage points (95% CI: −4.48 to −1.72; p<0.001). This association remained statistically significant after adjustment for potential confounding factors. Conclusion: Participation in clinical trials was associated with a more favorable evolution of vascular age over a 24-month period. The findings suggest that protocolized follow-up, enhanced adherence, and systematic cardiovascular risk management may contribute to improved vascular health outcomes.

References

Conroy RM, Pyörälä K, Fitzgerald AP, Sans S, Menotti A, De Backer G, et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J. 2003;24(11):987-1003.

Cuende JI. Vascular age versus cardiovascular risk: clarifying concepts. Rev Esp Cardiol (Engl Ed). 2016;69(3):243-6.

Cuende JI, Cuende N, Calaveras-Lagartos J. How to calculate vascular age with the SCORE project scales: a new method of cardiovascular risk evaluation. Eur Heart J. 2010;31(19):2351-8.

Perk J, De Backer G, Gohlke H, Graham I, Reiner Ž, Verschuren WMM, et al. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). Eur Heart J. 2012;33(13):1635-701.

Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Bäck M, et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021;42(34):3227-337.

SCORE2 Working Group and ESC Cardiovascular Risk Collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021;42(25):2439-54.

World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2024;331(14):1209-18.

McCambridge J, Witton J, Elbourne DR. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol. 2014;67(3):267-77.

Braunholtz DA, Edwards SJ, Lilford RJ. Are randomized clinical trials good for us (in the short term)? Evidence for a "trial effect". J Clin Epidemiol. 2001;54(3):217-24.

Vist GE, Bryant D, Somerville L, Birmingham T, Oxman AD. Outcomes of patients who participate in randomized controlled trials compared with similar patients receiving similar interventions who do not participate. Cochrane Database Syst Rev. 2008;(3):MR000009.

Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation. 2009;119(23):3028-35.

Chow CK, Teo KK, Rangarajan S, Islam S, Gupta R, Avezum A, et al. PURE Study Investigators. Prevalence, awareness, treatment, and control of hypertension and cardiovascular risk factors in high-, middle-, and low-income countries. Lancet. 2013;381(9867):611-9.

Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. Circulation. 2019;140(11):e596-e646.

Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2020;41(1):111-88.

Burnier M, Egan BM. Adherence in hypertension. Circ Res. 2019;124(7):1124-40

Sieben A, van Onzenoort HAW, van Dulmen S, van Laarhoven CJHM, van den Bemt BJF. Prior medication adherence of participants and non-participants of a randomized controlled trial to improve patient adherence in cardiovascular risk management. BMC Med Res Methodol. 2019;19:99. DOI: https://doi.org/10.1186/s12874-019-0743-7

Braunholtz DA, Edwards SJ, Lilford RJ. Are randomized clinical trials good for us (in the short term)? Evidence for a “trial effect”. J Clin Epidemiol. 2001;54(3):217-224. DOI: https://doi.org/10.1016/S0895-4356(00)00305-X

Vist GE, Hagen KB, Devereaux PJ, Bryant D, Kristoffersen DT, Oxman AD. Systematic review to determine whether participation in a trial influences outcome. BMJ. 2005;330(7501):1175. DOI: https://doi.org/10.1136/bmj.330.7501.1175

McCarney R, Warner J, Iliffe S, van Haselen R, Griffin M, Fisher P. The Hawthorne Effect: a randomised, controlled trial. BMC Med Res Methodol. 2007;7:30. https://doi.org/10.1186/1471-2288-7-30

Downloads

Published

2026-11-04

Issue

Section

Original

How to Cite

1.
Guerlloy F, Porcile R, Zaidman J. Comparison of Vascular Age Changes Over Two Time Periods Between Clinical Trial Participants and Patients Receiving Routine Outpatient Care. Interamerican Journal of Health Sciences [Internet]. 2026 Nov. 4 [cited 2026 Nov. 5];6:426. Available from: https://ijhsc.uai.edu.ar/index.php/ijhsc/article/view/426