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Cardiovascular PreventionHELENANCT05884840

New Cardiovascular Risk Screening Strategy.

A study testing HELENA in people with Cardiovascular Prevention and Screening, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Mortality due to cardiovascular disease (CVD) in Spain accounted for 29% of all deaths (32% in women and 26% in men) in 2017. Out of those, 67% were related to a coronary or a cerebrovascular disease . Read more about this study

Who is it for?
Ages 50 to 74 years
What is being tested?
HELENA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54,000 participants
Where
1 siteSpain
Study dates
20 Nov 2023to Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 50 to 74, which are free or do not have previous history of CVD. Patients that hold a REGICOR CV risk score ≥7, and REASON risk core ≥7, during a routine primary care visit

Who cannot join

  • Symptomatic PAD
  • Coronary disease
  • Stroke
  • Cardiac revascularization

Trial locations and contacts

1 site in 1 country.

Rafel Ramos Blanes, MD, PhD contact

+34 972 48 79 68

rramos.girona.ics@gencat.cat

Spain1 site, 1 recruiting

  • Institut Català de la Salut (ICS)

    Barcelona, 08007

    Rafel Ramos Blanes, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: Health Program for prEvention of cardiovascuLar disEases Based on a Risk screeNing Strategy With Ankle-brachial Index.

Mortality due to cardiovascular disease (CVD) in Spain accounted for 29% of all deaths (32% in women and 26% in men) in 2017. Out of those, 67% were related to a coronary or a cerebrovascular disease .

A key strategy in primary prevention of CVD is to use risk functions to individualize preventive interventions for each patient. The current CV risk-screening program in some regions of Spain, is based using an adapted Framingham scale, REGICOR's risk function, which is integrated in the primary care electronic health record. This risk function predicts the probability within 10 years of developing a coronary event. However, this function fails to identify patients that fall into low- or intermediate-risk level, and might develop a CV event in the up following 10 years.

Read more

Ankle-brachial index (ABI) is a simple, non-invasive and economic technique, which allows detecting peripheral arterial disease (PAD), and gives independent risk function information compared to other coronary risk functions. Even tough, between 13-27% of middle age population have an ABI ≤ 9, around 50-89% of them do not exhibit any symptoms. However, they hold higher mortality risk and CV events. Current clinical guidelines for PAD screening, have a limited level of evidence, and only recommend using ABI on patients aged 50-70, who have diabetes or are smokers, and patients older than 70 years old.

A new risk function, REASON, to assess CVD risk has been designed. This model has proven to improve predictive capacity of holding an ABI ≤ 0.9 on those patients aged 50-74 that are apparently free of CVD. Therefore, a strategy that combines the current CV risk estimation using REGICOR, and the prediction capacity of pathologic ABI with REASON, would allow detecting high-risk patients with a PAD screening program. It is possible that patients, who hold an ABI ≤ 0.9, even if being asymptomatic, will adopt physician's recommendations on healthy life habits and preventive treatment.

The aims of this study are:

  • To assess the effectiveness and cost-utility of adding a screening program with ABI to the current strategy of CV risk detection to reduce the incidence of CVD and mortality from all causes in the population aged 50 to 74.
  • To assess the effectiveness of adding a screening program with ABI to the current strategy of CV risk detection to improve cardiovascular risk factors in the population aged 50 to 74.
Being tested
HELENA
Medical subject headings
Peripheral Arterial Disease, Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HELENADiagnostic test

    The current CV risk screening program in based using the REGICOR risk function, which is integrated in the primary care electronic health record. This risk function predicts the probability within 10 years of developing a coronary event. Those who are categorized as high risk, obtaining a 10% of probability, are candidates of receiving lipid lowering drugs and recommendations on healthy life habits.

    What this intervention suggests is that, besides the REGICOR estimation, the electronic health records will also incorporate a new CV risk function, REASON. The model predicts the risk of holding a pathologic ABI score, in people aged 50-74 years old who are apparently free of CV. Patients who obtain a score ≥ 7 will undergo a PAD screening program with ABI test. If the value of the test is ≤0.9, the REGICOR, physicians will recommend indications of the Health Catalan Institute's CV and lipid Guidelines to the patients.

Study groups in NCT05884840
Study groupRoleWhat they receive
Intervention group PAD screening programExperimentalPatients aged 50-74 years free of any symptomatic or history of CVD and a Framingham-REGICOR risk ≥7%, will be candidates for PAD screening program using REASON's function predicative capacity
Receives: Diagnostic Test: HELENA
Control group PAD screening programNo interventionPatients aged 50-74 years free of any symptomatic or history of CVD will be candidates as a comparison group to calculate the cost-utility and reduction of CVD risk and events.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hard coronary heart disease (CHD)

    Myocardial infarction, cardiac revascularization, or coronary death

    Measured: 3 years

  2. Major adverse cardiovascular event (MACE)

    A composite of hard CHD (myocardial infarction, cardiac revascularization, or coronary death) and stroke (fatal and nonfatal ischemic stroke)

    Measured: 3 years

  3. All-cause mortality

    Measured: 3 years

  4. Tabaco consumption (CVD risk factors improvement assessment)

    Smoker, ex-smoker or non-smoker

    Measured: 3 years

  5. Lipid profile (CVD risk factors improvement assessment)

    Total cholesterol (mg/dl), LDL (mg/dl), HDL (mg/dl), Triglycerides (mg/dl)

    Measured: 3 years

  6. Systolic and diastolic pressure (CVD risk factors improvement assessment)

    mm Hg

    Measured: 3 years

  7. Weight (CVD risk factors improvement assessment)

    kg

    Measured: 3 years

  8. Height (CVD risk factors improvement assessment)

    m

    Measured: 3 years

  9. BMI (CVD risk factors improvement assessment)

    (kg/m2) Will be calculated dividing the weight in kilograms by their height in metres squared

    Measured: 3 years

  10. Glycaemia (CVD risk factors improvement assessment)

    Fasting blood sugar (mg/dl)

    Measured: 3 years

  11. Glycated haemoglobin (CVD risk factors improvement assessment)

    (in DM patients) glycosylated hemoglobin in the blood (mg/dl) or percentage (%)

    Measured: 3 years

  12. Creatinine (CVD risk factors improvement assessment)

    mg/dL

    Measured: 3 years

  13. Proteinuria (CVD risk factors improvement assessment)

    mg/dL protein in urine

    Measured: 3 years

  14. Albumin-to-creatinine ratio (ACR) (CVD risk factors improvement assessment)

    ACR (mg/g) will be calculated by by dividing mg of proteinuria (albumine) by g of creatinine.

    Measured: 3 years

  15. Glomerular filtrate rate (CVD risk factors improvement assessment)

    Levels of creatinine in milliliters of cleansed blood per minute per body surface (mL/min/1.73m2).

    Measured: 3 years

Secondary outcomes (4)

  1. Coronary heart disease

    A composite of angina and hard CHD

    Measured: 3 years

  2. Cerebrovascular disease

    A composite of stroke (fatal and nonfatal ischemic stroke) and transient ischemic attack

    Measured: 3 years

  3. Cardiovascular disease

    a composite of MACE, angina and transient ischemic attack

    Measured: 3 years

  4. Lipid lowering medication Adverse effects

    1. Short-term effects: Muscular and hepatic alterations, and 2) long-term effects: Diabetes and cancer

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2023
  2. Study start20 Nov 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be conducted as a clustered randomized pragmatic clinical trial (CRT) in primary care practice. During the period of two years (2023-2025), randomization of the eight Health Regions (274 primary care centres) in Catalonia will take place. The current strategy, in Catalonia, for cardiovascular risk screening is based on risk assessment using Framingham-REGICOR risk function. In the intervention group, a screening program with ABI will be added to all 50-74-year-old individuals with Framingham-REGICOR risk ≥7% and high probability of having ABI≤0.9. The probability of having ABI≤0.9 will be estimated using the REASON function and will be defined as a probability ≥7%. People that are classified as ABI≤0.9 high-risk, will undergo a PAD screening program using ABI test. If the result of the ABI is equal and lower than 0.9, indications of the Health Catalan Institute's CV and lipid guidelines will be recommended by physicians to the patients.
Masking
None (open label)
Enrolment
54,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05884840
Sponsor's protocol ID
SLT/21/000015
Acronym
HELENA
Status last verified
Dec 2023
First submitted
10 May 2023
Last updated
29 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ministerio de Sanidad SS e I. Indicadores de Salud 2020 Evolución de los indicadores del estado de salud en España y su magnitud en el contexto de la Unión Europea. Madrid; 2020.

  • Institute for Health Metrics and Evaluation. Global Burden of Disease Results Tool, Global Health Data Exchange. 2017

  • Wilkins E, et al. European Cardiovascular Disease Statistics. European Heart Network, editor. Brussels; 2017

  • Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.

    PubMed 34458905

  • Comin E, Solanas P, Cabezas C, Subirana I, Ramos R, Gene-Badia J, Cordon F, Grau M, Cabre-Vila JJ, Marrugat J. [Estimating cardiovascular risk in Spain using different algorithms]. Rev Esp Cardiol. 2007 Jul;60(7):693-702. Spanish.

    PubMed 17663853

  • Morrow DA, de Lemos JA. Benchmarks for the assessment of novel cardiovascular biomarkers. Circulation. 2007 Feb 27;115(8):949-52. doi: 10.1161/CIRCULATIONAHA.106.683110. No abstract available.

    PubMed 17325253

  • Grewal J, Anand S, Islam S, Lonn E; SHARE and SHARE-AP Investigators. Prevalence and predictors of subclinical atherosclerosis among asymptomatic "low risk" individuals in a multiethnic population. Atherosclerosis. 2008 Mar;197(1):435-42. doi: 10.1016/j.atherosclerosis.2007.06.020. Epub 2007 Aug 6.

    PubMed 17675040

  • Greenland P, Abrams J, Aurigemma GP, Bond MG, Clark LT, Criqui MH, Crouse JR 3rd, Friedman L, Fuster V, Herrington DM, Kuller LH, Ridker PM, Roberts WC, Stanford W, Stone N, Swan HJ, Taubert KA, Wexler L. Prevention Conference V: Beyond secondary prevention: identifying the high-risk patient for primary prevention: noninvasive tests of atherosclerotic burden: Writing Group III. Circulation. 2000 Jan 4;101(1):E16-22. doi: 10.1161/01.cir.101.1.e16. No abstract available.

    PubMed 10618318

  • McDermott MM, Greenland P, Liu K, Guralnik JM, Celic L, Criqui MH, Chan C, Martin GJ, Schneider J, Pearce WH, Taylor LM, Clark E. The ankle brachial index is associated with leg function and physical activity: the Walking and Leg Circulation Study. Ann Intern Med. 2002 Jun 18;136(12):873-83. doi: 10.7326/0003-4819-136-12-200206180-00008.

    PubMed 12069561

  • Ramos R, Quesada M, Solanas P, Subirana I, Sala J, Vila J, Masia R, Cerezo C, Elosua R, Grau M, Cordon F, Juvinya D, Fito M, Isabel Covas M, Clara A, Angel Munoz M, Marrugat J; REGICOR Investigators. Prevalence of symptomatic and asymptomatic peripheral arterial disease and the value of the ankle-brachial index to stratify cardiovascular risk. Eur J Vasc Endovasc Surg. 2009 Sep;38(3):305-11. doi: 10.1016/j.ejvs.2009.04.013. Epub 2009 Jun 10.

    PubMed 19515589

  • Heald CL, Fowkes FG, Murray GD, Price JF; Ankle Brachial Index Collaboration. Risk of mortality and cardiovascular disease associated with the ankle-brachial index: Systematic review. Atherosclerosis. 2006 Nov;189(1):61-9. doi: 10.1016/j.atherosclerosis.2006.03.011. Epub 2006 Apr 18.

    PubMed 16620828

  • Ankle Brachial Index Collaboration; Fowkes FG, Murray GD, Butcher I, Heald CL, Lee RJ, Chambless LE, Folsom AR, Hirsch AT, Dramaix M, deBacker G, Wautrecht JC, Kornitzer M, Newman AB, Cushman M, Sutton-Tyrrell K, Fowkes FG, Lee AJ, Price JF, d'Agostino RB, Murabito JM, Norman PE, Jamrozik K, Curb JD, Masaki KH, Rodriguez BL, Dekker JM, Bouter LM, Heine RJ, Nijpels G, Stehouwer CD, Ferrucci L, McDermott MM, Stoffers HE, Hooi JD, Knottnerus JA, Ogren M, Hedblad B, Witteman JC, Breteler MM, Hunink MG, Hofman A, Criqui MH, Langer RD, Fronek A, Hiatt WR, Hamman R, Resnick HE, Guralnik J, McDermott MM. Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis. JAMA. 2008 Jul 9;300(2):197-208. doi: 10.1001/jama.300.2.197.

    PubMed 18612117

  • Espinola-Klein C, Rupprecht HJ, Bickel C, Lackner K, Savvidis S, Messow CM, Munzel T, Blankenberg S; AtheroGene Investigators. Different calculations of ankle-brachial index and their impact on cardiovascular risk prediction. Circulation. 2008 Aug 26;118(9):961-7. doi: 10.1161/CIRCULATIONAHA.107.763227. Epub 2008 Aug 12.

    PubMed 18697822

  • US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Peripheral Artery Disease and Cardiovascular Disease Risk Assessment With the Ankle-Brachial Index: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Jul 10;320(2):177-183. doi: 10.1001/jama.2018.8357.

    PubMed 29998344

  • Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.

    PubMed 17140820

Questions about this trial

What is this clinical trial studying?

A study testing HELENA in people with Cardiovascular Prevention and Screening, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rafel Ramos Blanes, MD, PhD (+34 972 48 79 68, rramos.girona.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hard coronary heart disease (CHD) (time frame: 3 years). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05884840, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

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