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Cardiovascular (CV) RiskNCT07869069

Advancing Health Equity and Preventive Cardiovascular Care in Indigenous and Remote Communities: a Mobile Healthcare Unit

A study testing Cardiovascular risk screening and Follow-up of cardiovascular risk factors in people with Cardiovascular (CV) Risk and Metabolic Health, run by Laval University at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Indigenous people living in Canada face significant healthcare inequities, particularly in basic, primary, and secondary prevention, leading to higher rates of cardiovascular disease and mortality. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
What is being tested?
Cardiovascular risk screening and Follow-up of cardiovascular risk factors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteCanada
Study dates
11 Feb 2026to 31 Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BMI > 27 kg/m^2

Who cannot join

  • Being pregnant;
  • Known heart condition

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • IUCPQ-ULaval

    Québec, Quebec

    Coordinator, 1-418-656-8711, santeinclusive@criucpq.ulaval.ca

    Recruiting

Other trials in Canada

About this study

Indigenous people living in Canada face significant healthcare inequities, particularly in basic, primary, and secondary prevention, leading to higher rates of cardiovascular disease and mortality. This program aims to develop a comprehensive understanding of the contextual and individual determinants influencing Indigenous health, and to address health disparities by using tailored community-led participatory research and care initiatives. The investigator and research team use a Mobile Healthcare Unit travelling to Indigenous communities, providing customized, impactful, and sustainable preventive care that adapts dynamically to the evolving needs of each community. The initiative places a strong emphasis on equity and inclusivity, aiming to generate original data in Indigenous and remote underrepresented/underserved populations. This proposal will improve opportunities of identifying facilitators and barriers to preventive care in Indigenous and remote communities. This focus is vital for reducing health disparities and aligns with the Truth and Reconciliation Calls to Action. To maximize knowledge mobilization and ensure culturally appropriate initiatives align with community needs and priorities, this research program collaborates with the Indigenous University Hub at Laval University, local community members and leaders, and Indigenous peoples with lived experience. Existing national and international collaborations with Indigenous communities further enhance the initiative's potential impact and foster knowledge mobilization on a global scale. The ultimate goal is to empower Indigenous peoples and communities to advocate for systemic changes to fight inequities in healthcare in accordance with appropriated truth and reconciliation efforts.

Read the detailed description

This pilot study will take place in the Mobile Healthcare Unit (motorized vehicle) that will travel to 10 Indigenous and/or remote communities.This study aims at collecting cardiovascular (CV) data and delivering culturally appropriate research and care in underserved/underrepresented populations. Collaborating members of the communities visited will be involve in the mobile care service and will assist as translators. Recruitment and data collection will be carried out by the investigator at the IUCPQ-ULaval in collaboration with the participating communities. This study was co-designed and accepted by health departments and participating communities. Each participant will undergo a comprehensive assessment of CV risk factors and CV conditions at the beginning of the study. This assessment will be standardized and will include the following elements:

  • Clinical examination including anthropometric measurements;
  • Auscultation by a cardiologist with a digital stethoscope;
  • Translated and validated questionnaires on demographics and medical history;
  • Pregnancy and reproductive health questionnaires;
  • Blood pressure, assessed by oscillometry;
  • Peripheral artery disease assessment;
  • Cardiometabolic blood markers (NT-proBNP, HbA1C, hs-CRP, CBC, lipids, etc.)
  • Arrythmia and atrial fibrillation, assessed by electrocardiogram;
  • Anthropometric indices and body fat distribution by elastography;
  • Maximal stress test on a treadmill;
  • Questionnaire on participant satisfaction and areas of improvement in health equity.
Being tested
Cardiovascular risk screening, Follow-up of cardiovascular risk factors
Keywords
Cardiovascular Disease, Cardiovascular-Kidnay-Metabolic Health, Community-Driven AND Culturally Safe Care and Research, Diabetes, Health Equity and Inclusivity, Indigenous Health, Mobile Healthcare Unit, Preventive Care, Social Determinants of Health, Women's Health
Medical subject headings
Cardiovascular Diseases, Diabetes Mellitus

What participants receive

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

  • Cardiovascular risk screeningOther

    Extensive cardiovascular risk screening offered locally in underserved/ underrepresented communities (see Study Description for more details)

  • Follow-up of cardiovascular risk factorsOther

    Measure changes in cardiovascular risk factors among participants who took place in the screening phase.

Study groups in NCT07869069
Study groupRoleWhat they receive
Preventive careOtherNot described
Receives: Other: Cardiovascular risk screening; Other: Follow-up of cardiovascular risk factors

What is being measured

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

  1. Height in meters

    Measured using a stadiometer

    Measured: Once, at baseline.

  2. Weight in kilograms

    Measured using an electronic body scale

    Measured: At baseline and at 1 year

  3. Body mass index in kg/(m^2)

    BMI will be calculated by dividing the weight in kilograms by the square of the height in meters

    Measured: At baseline and at 1 year

  4. Waist circumference in centimeters

    Waist circumference will be measured using an ergonomic circumference measuring tape

    Measured: At baseline and at 1 year

  5. Blood pressure

    In mm Hg, using a digital blood pressure device

    Measured: At baseline and at one-year follow-up

  6. Lipid profile

    Assessment of hypercholesterolemia (LDL-C, HDL-C, triglycerides, non-HDL-C in mmol/L) and apoB levels in g/L.

    Measured: At baseline and at one-year follow-up

  7. Physical activity measure

    Using the International Physical Activity Questionnaire (IPAQ)

    Measured: At baseline and at one-year follow-up

  8. Glycated hemoglobin (HbA1c)

    Blood test, expressed as %

    Measured: At baseline and at one-year follow-up

  9. Dietary habits

    Frequency of intake per month of fruits, vegetables, whole grains, lean proteins, saturated fats and added sugars, using the Canadian Food Intake Screener.

    Measured: At baseline and at one-year follow-up

  10. Smoking habits

    Self-reported smoking habits as current smoker, former smoker or never smoked, as well as frequency of smoking

    Measured: At baseline and at one-year follow-up

  11. Framingham risk score

    Estimated 10-year cardiovascular risk, expressed as a percentage (%)

    Measured: At baseline and at one-year follow-up

Secondary outcomes (1)
  1. Participant feedback on intervention

    Questionnaire on participant satisfaction and areas of improvement in health equity.

    Measured: At baseline and at one-year follow-up

Timeline

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

  1. First posted9 Oct 2026
  2. Study start11 Feb 2026
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07869069
Sponsor's protocol ID
543568
Status last verified
Oct 2026
First submitted
24 Feb 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: According to OCAP(TM) principles, each community owns their data, controls its dissemination, and decides when and what research is in the best interests of their specific community.

Publications

  • Lajeunesse-Trempe F, Boit MK, Kaduka LU, De Lucia-Rolfe E, Baass A, Paquette M, Piche ME, Tchernof A, Christensen DL. Validation of the Fatty Liver Index for identifying non-alcoholic fatty liver disease in a Kenyan population. Trop Med Int Health. 2023 Oct;28(10):830-838. doi: 10.1111/tmi.13927. Epub 2023 Aug 31.

    PubMed 37650501
  • Leveille N, Provost H, Keutcha Kamani C, Chen M, Deghan Manshadi S, Ades M, Shanahan K, Nauche B, Drudi LM. Exploring Prognostic Implications of Race and Ethnicity in Patients With Peripheral Arterial Disease. J Surg Res. 2024 Oct;302:739-754. doi: 10.1016/j.jss.2024.07.120. Epub 2024 Aug 30.

    PubMed 39216457
  • Lajeunesse-Trempe F, Piche ME, Kaduka L, Lopez Y Taylor JR, Sagastume RC. Moving from helicopter research to proximity research and capacity building. Trends Endocrinol Metab. 2025 Mar;36(3):193-195. doi: 10.1016/j.tem.2024.08.011. Epub 2024 Oct 1.

    PubMed 39358160
  • Lane-Cordova AD, Khan SS, Grobman WA, Greenland P, Shah SJ. Long-Term Cardiovascular Risks Associated With Adverse Pregnancy Outcomes: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Apr 30;73(16):2106-2116. doi: 10.1016/j.jacc.2018.12.092.

    PubMed 31023435
  • Powell-Wiley TM, Poirier P, Burke LE, Despres JP, Gordon-Larsen P, Lavie CJ, Lear SA, Ndumele CE, Neeland IJ, Sanders P, St-Onge MP; American Heart Association Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Epidemiology and Prevention; and Stroke Council. Obesity and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021 May 25;143(21):e984-e1010. doi: 10.1161/CIR.0000000000000973. Epub 2021 Apr 22.

    PubMed 33882682
  • Norris CM, Yip CYY, Nerenberg KA, Clavel MA, Pacheco C, Foulds HJA, Hardy M, Gonsalves CA, Jaffer S, Parry M, Colella TJF, Dhukai A, Grewal J, Price JAD, Levinsson ALE, Hart D, Harvey PJ, Van Spall HGC, Sarfi H, Sedlak TL, Ahmed SB, Baer C, Coutinho T, Edwards JD, Green CR, Kirkham AA, Srivaratharajah K, Dumanski S, Keeping-Burke L, Lappa N, Reid RD, Robert H, Smith G, Martin-Rhee M, Mulvagh SL. State of the Science in Women's Cardiovascular Disease: A Canadian Perspective on the Influence of Sex and Gender. J Am Heart Assoc. 2020 Feb 18;9(4):e015634. doi: 10.1161/JAHA.119.015634. Epub 2020 Feb 17. No abstract available.

    PubMed 32063119
  • Reading J. Confronting the Growing Crisis of Cardiovascular Disease and Heart Health Among Aboriginal Peoples in Canada. Can J Cardiol. 2015 Sep;31(9):1077-80. doi: 10.1016/j.cjca.2015.06.012. Epub 2015 Jun 21.

    PubMed 26321431
  • Piche ME, Tchernof A, Despres JP. Obesity Phenotypes, Diabetes, and Cardiovascular Diseases. Circ Res. 2020 May 22;126(11):1477-1500. doi: 10.1161/CIRCRESAHA.120.316101. Epub 2020 May 21.

    PubMed 32437302
  • Aziz H, Marchand M, Pop C, King A, Anand SS, Arbour L, Atzema C, Spaziano M, Merveille N, Filimon S, Poirier P, Huynh T. A Call to Action: Optimizing Indigenous Cardiovascular Health in Canada. Can J Cardiol. 2022 Oct;38(10):1584-1587. doi: 10.1016/j.cjca.2022.06.011. Epub 2022 Jun 16. No abstract available.

    PubMed 35718241
  • Lajeunesse-Trempe F, Piche ME, Poirier P, Tchernof A, Ayotte P. Adiposity Phenotypes and Associated Cardiometabolic Risk Profile in the Inuit Population of Nunavik. Nutrients. 2024 Mar 2;16(5):725. doi: 10.3390/nu16050725.

    PubMed 38474854
  • Anand SS, Abonyi S, Arbour L, Balasubramanian K, Brook J, Castleden H, Chrisjohn V, Cornelius I, Davis AD, Desai D, de Souza RJ, Friedrich MG, Harris S, Irvine J, L'Hommecourt J, Littlechild R, Mayotte L, McIntosh S, Morrison J, Oster RT, Picard M; Pictou Landing First Nation; Poirier P, Schulze KM, Toth EL; Canadian Alliance for Healthy Hearts and Minds First Nations Research Group. Explaining the variability in cardiovascular risk factors among First Nations communities in Canada: a population-based study. Lancet Planet Health. 2019 Dec;3(12):e511-e520. doi: 10.1016/S2542-5196(19)30237-2.

    PubMed 31868600

Questions about this trial

What is this clinical trial studying?

A study testing Cardiovascular risk screening and Follow-up of cardiovascular risk factors in people with Cardiovascular (CV) Risk and Metabolic Health, run by Laval University at 1 site in Canada.

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 2 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Coordinator (1-418-656-8711, santeinclusive@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Height in meters (time frame: Once, at baseline.). The study lists 11 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 NCT07869069, which also lists 11 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 9 Oct 2026.

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