Cardiovascular DiseasesNCT07539987
Evaluation of a Novel Indoor Air Pollution Intervention Among Older Adults
A study testing Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE) in people with Cardiovascular Diseases and Blood Pressure, run by University of Montana at 1 site in United States.
Trial summary
Particulate matter air pollution is the leading environmental risk factor of cardiovascular disease and is increasing in the Western United States due to more frequent and severe wildfires. Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Cardiovascular Diseases, Blood Pressure, Glycated Hemoglobin (HbA1c)
- What is being tested?
- Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Jul 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 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55-79 years of age one primary residence (5+ days per week)
- have an electronic device, email address, and reliable internet at home for survey submission
Who cannot join
- current smoking of any kind or living in a household with someone who currently smokes
- current use of a portable air cleaner unit at home
- plans to move in the next year
- previous physician-diagnosed cardiovascular disease (coronary heart disease [myocardial infarction], stroke, or heart failure)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Montana
Missoula, Montana, 59812
Ethan S Walker, PhD, 406-243-2063, ethan.walker@umontana.edu
About this study
Particulate matter air pollution is the leading environmental risk factor of cardiovascular disease and is increasing in the Western United States due to more frequent and severe wildfires. Older adults are particularly susceptible to both air pollution exposures and the development of cardiovascular disease, and the older adult population in the United States is rapidly growing. Given the converging threats of worsening air quality and an aging population, this clinical trial will evaluate a novel, multifaceted indoor air quality intervention to improve cardiovascular health outcomes among older adults in the wildfire-impacted state of Montana.
Read the detailed description
Particulate matter (PM) air pollution is the leading risk factor of global disease burden and the largest environmental risk factor for premature death and cardiovascular disease (CVD). Older adults are particularly susceptible to air pollution exposures and the development of CVD as they often have underlying health conditions. PM levels are rising in the Western United States (US) as wildfires have increased, with up to 50% of fine PM (PM2.5; particles <2.5 µm in diameter) in some Western regions now attributed to wildfires. Recent research indicates there is often a substantial increase in indoor PM2.5 when outdoor PM2.5 increases, including during wildfire events. Improving indoor air quality is critically important as US adults spend 90% of their time indoors where air quality is impacted by numerous indoor and outdoor air pollution sources. New strategies are needed to improve indoor air quality and CVD health outcomes, particularly as the US population rapidly ages and the number of susceptible older adults grows. There is evidence that filtering indoor air with portable air cleaners (PACs) can result in short-term PM2.5 improvements. However, evidence is limited that PAC use meaningfully improves health, particularly in studies of longer duration. In response to this need, the investigators have developed a household indoor air quality intervention called AIRWISE (Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education). AIRWISE promotes sustained improvements in indoor air quality through education, behavioral cues, and equipment including PACs and PM2.5 sensors that display real-time data. In this project, the investigators will evaluate the AIRWISE intervention among older adults in the wildfire-impacted US state of Montana. In Aim 1, the investigators will conduct a randomized trial to test the efficacy of the AIRWISE intervention on PREVENT (Predicting Risk of CVD EVENTs), a validated CVD risk score. The central hypothesis is that PREVENT will be improved among older adults who use AIRWISE compared to controls who use only PACs. The rationale is that the AIRWISE intervention will promote sustained improvements in indoor air quality and CVD risk, a significant advance beyond PACs alone that are widely recommended yet have inconsistent benefits on long-term health. In Aim 2, the investigators will use Aim 1 data to determine associations between indoor PM2.5 concentrations and PREVENT. The investigators will use additional models between PM2.5 and the individual components of PREVENT as outcomes in order to determine which risk factors are most impacted by PM2.5 and inform underlying subclinical mechanisms. In Aim 3, the investigators will model the economic costs and benefits of indoor PM2.5 improvements and the AIRWISE intervention to inform policy-level action. With the converging threats of increasing air pollution due to wildfires and an aging US population, this project will contribute to identifying actionable strategies to improve indoor air quality and decrease CVD risk among older adults.
- Conditions
- Cardiovascular Diseases, Blood Pressure, Glycated Hemoglobin (HbA1c), Cholesterol, Cholesterol, HDL, Cholesterol, LDL
- Being tested
- Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), Portable Air Cleaner (PAC) Control
- Medical subject headings
- Cardiovascular Diseases, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE)Behavioural
The AIRWISE intervention consists of a 3-pronged approach grounded in the Health Belief Model (HBM) to improve residential indoor air quality through education, equipment, and behavioral cues. To reinforce cues to action, AIRWISE uses alerts from air quality sensors, prompting timely behavioral responses. Specifically, indoor and outdoor air quality alerts act as behavioral cues to promote active engagement and reference a decision matrix with specific recommendations based indoor and outdoor air quality. Recommendations on the decision matrix include simple strategies to reduce air pollution exposures, including increasing use and fan speed of portable air cleaners, opening or closing windows to change ventilation, and changing activities such as physical activity, cooking, and cleaning. This integrated approach promotes sustained behavior change by aligning with all key HBM constructs.
Portable Air Cleaner (PAC) ControlOther
Participants will use two PACs in their home according to manufacturer recommendations. PAC Control group participants will not receive further education on air quality or recommendations on PAC use, nor will they receive additional equipment or outdoor AQI alerts. Control participants will use and maintain the PACs at their own discretion.
| Study group | Role | What they receive |
|---|---|---|
| AIRWISE Intervention | Experimental | Participants randomized to the AIRWISE Intervention group will use AIRWISE in their homes for 12 months. The AIRWISE group will use two PACs to filter indoor air and two optical PM2.5 sensors with lights that change color in real time according to AQI. In addition, automated outdoor air quality alerts are sent via text and email when outdoor AQI goes above 75 (mid-point of the Moderate AQI category). Outdoor air quality will be referenced from the Environmental Protection Agency or PurpleAir monitor nearest to the participant's home. Based on the indoor and outdoor AQI levels, participants will reference a decision matrix and educational materials to make informed decisions on improving indoor air quality. Education and behavioral strategies are delivered through multiple approaches, including visual aids, handouts, videos, and a magnet with the decision matrix that can be placed in an accessible location in the home. Receives: Behavioral: Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE) |
| PAC Control | Active comparator | Participants randomized to the PAC Control group will use two PACs in their home without additional AIRWISE equipment/education. After randomization, they will be given instructions on study procedures and using the PAC units according to manufacturer recommendations. PAC Control group participants will not receive further education on air quality or recommendations on PAC use, nor will they receive additional equipment or outdoor AQI alerts. They will receive PurpleAir sensors without an AQI light that are for data collection purposes only, and they will not have access to the data throughout the study. Control participants will use and maintain the PACs at their own discretion. At the end of their participation, they will have the option of receiving the additional AIRWISE components. Receives: Other: Portable Air Cleaner (PAC) Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicting Risk of CVD EVENTs (PREVENT) Score
Validated cardiovascular disease (CVD) risk score called Predicting Risk of CVD EVENTs (PREVENT). The score is a percentage ranging from 0 to 100 that indicates percentage risk of developing CVD, with higher scores indicating higher risk of developing CVD.
Measured: 0, 6, 12 months
Secondary outcomes (18)
Life's Essential 8 (LE8) Score
Validated metric of cardiovascular health called Life's Essential 8 (LE8). The score ranges from 0 to 100, with higher scores indicating better cardiovascular health and lower risk of adverse cardiovascular outcomes.
Measured: 0, 6, 12 months
Indoor PM2.5
Fine particulate matter (PM2.5), or particles that are less than 2.5 micrometers in aerodynamic diameter and a primary component of air pollution
Measured: Continuous at 2-minute intervals
Indoor VOCs
Volatile Organic Compounds (VOCs), a component of air pollution
Measured: Continuous at 2-minute intervals
Glycated hemoglobin
A measure of blood sugar levels measured through venous blood draw and used to calculate the primary PREVENT outcome
Measured: 0, 6, 12 months
Estimated Glomerular Filtration Rate
A measure of kidney function measured through venous blood draw and used to calculate the primary PREVENT outcome
Measured: 0, 6, 12 months
Total cholesterol
Measured through venous blood draw and used to calculate the primary PREVENT outcome
Measured: 0, 6, 12 months
HDL cholesterol
High-density lipoprotein cholesterol measured through venous blood draw and used to calculate the primary PREVENT outcome
Measured: 0, 6, 12 months
LDL cholesterol
Low-density lipoprotein cholesterol measured through venous blood draw and used to calculate the primary PREVENT outcome
Measured: 0, 6, 12 months
CRP
C-reactive protein, a measure of inflammation measured through venous blood draw
Measured: 0, 6, 12 months
ESR
Erythrocyte sedimentation rate, used as a measure of inflammation measured through venous blood draw
Measured: 0, 6, 12 months
Uric acid
Used as a measure of inflammation measured through venous blood draw
Measured: 0, 6, 12 months
CBC
Used as a measure of inflammation measured through venous blood draw
Measured: 0, 6, 12 months
Systolic and diastolic blood pressure
A risk factor for CVD and used to calculate the primary PREVENT outcome
Measured: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Health symptoms
Health symptoms will be reported in a questionnaire and used as a measure of quality of life. The questionnaire includes 6 questions and asks about recent illness and frequency of symptoms including eye irritation, blurred vision, wheezing, cough, throat irritation, difficulty breathing, excessive mucus, nose irritation, and headache.
Measured: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Physical activity
A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome. Physical activity will be reported in a questionnaire. The questionnaire includes 12 questions and asks about type, duration, and location of recent physical activities.
Measured: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Sleep quality
A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome. Sleep quality will be reported in a questionnaire. The questionnaire includes 9 questions and asks about duration, quality, barriers, and facilitators of sleep over the previous month.
Measured: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Diet
A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome. Diet will be reported in a questionnaire. The questionnaire includes 16 questions and asks about the recent frequency and amount of consuming 16 different types of foods.
Measured: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
BMI
A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539987
- Sponsor's protocol ID
- 25-0467
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Indoor Air Pollution Intervention Among Older Adults
- ClinicalTrials.gov ID
- NCT07539987
- Acronym / sponsor ID
- 25-0467
- Conditions
- Cardiovascular Diseases, Blood Pressure, Glycated Hemoglobin (HbA1c), Cholesterol, Cholesterol, HDL, Cholesterol, LDL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Particulate matter air pollution is the leading environmental risk factor of cardiovascular disease and is increasing in the Western United States due to more frequent and severe wildfires. Older adults are particularly susceptible to both air pollution exposures and the development of cardiovascular disease, and the older adult population in the United States is rapidly growing. Given the converging threats of worsening air quality and an aging population, this clinical trial will evaluate a novel, multifaceted indoor air quality intervention to improve cardiovascular health outcomes among older adults in the wildfire-impacted state of Montana.
Detailed description
Particulate matter (PM) air pollution is the leading risk factor of global disease burden and the largest environmental risk factor for premature death and cardiovascular disease (CVD). Older adults are particularly susceptible to air pollution exposures and the development of CVD as they often have underlying health conditions. PM levels are rising in the Western United States (US) as wildfires have increased, with up to 50% of fine PM (PM2.5; particles <2.5 µm in diameter) in some Western regions now attributed to wildfires. Recent research indicates there is often a substantial increase in indoor PM2.5 when outdoor PM2.5 increases, including during wildfire events. Improving indoor air quality is critically important as US adults spend 90% of their time indoors where air quality is impacted by numerous indoor and outdoor air pollution sources. New strategies are needed to improve indoor air quality and CVD health outcomes, particularly as the US population rapidly ages and the number of susceptible older adults grows. There is evidence that filtering indoor air with portable air cleaners (PACs) can result in short-term PM2.5 improvements. However, evidence is limited that PAC use meaningfully improves health, particularly in studies of longer duration. In response to this need, the investigators have developed a household indoor air quality intervention called AIRWISE (Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education). AIRWISE promotes sustained improvements in indoor air quality through education, behavioral cues, and equipment including PACs and PM2.5 sensors that display real-time data. In this project, the investigators will evaluate the AIRWISE intervention among older adults in the wildfire-impacted US state of Montana. In Aim 1, the investigators will conduct a randomized trial to test the efficacy of the AIRWISE intervention on PREVENT (Predicting Risk of CVD EVENTs), a validated CVD risk score. The central hypothesis is that PREVENT will be improved among older adults who use AIRWISE compared to controls who use only PACs. The rationale is that the AIRWISE intervention will promote sustained improvements in indoor air quality and CVD risk, a significant advance beyond PACs alone that are widely recommended yet have inconsistent benefits on long-term health. In Aim 2, the investigators will use Aim 1 data to determine associations between indoor PM2.5 concentrations and PREVENT. The investigators will use additional models between PM2.5 and the individual components of PREVENT as outcomes in order to determine which risk factors are most impacted by PM2.5 and inform underlying subclinical mechanisms. In Aim 3, the investigators will model the economic costs and benefits of indoor PM2.5 improvements and the AIRWISE intervention to inform policy-level action. With the converging threats of increasing air pollution due to wildfires and an aging US population, this project will contribute to identifying actionable strategies to improve indoor air quality and decrease CVD risk among older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIRWISE Intervention | Experimental | Behavioral: Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE)Participants randomized to the AIRWISE Intervention group will use AIRWISE in their homes for 12 months. The AIRWISE group will use two PACs to filter indoor air and two optical PM2.5 sensors with lights that change color in real time according to AQI. In addition, automated outdoor air quality alerts are sent via text and email when outdoor AQI goes above 75 (mid-point of the Moderate AQI category). Outdoor air quality will be referenced from the Environmental Protection Agency or PurpleAir monitor nearest to the participant's home. Based on the indoor and outdoor AQI levels, participants will reference a decision matrix and educational materials to make informed decisions on improving indoor air quality. Education and behavioral strategies are delivered through multiple approaches, including visual aids, handouts, videos, and a magnet with the decision matrix that can be placed in an accessible location in the home. |
| PAC Control | Active comparator | Other: Portable Air Cleaner (PAC) ControlParticipants randomized to the PAC Control group will use two PACs in their home without additional AIRWISE equipment/education. After randomization, they will be given instructions on study procedures and using the PAC units according to manufacturer recommendations. PAC Control group participants will not receive further education on air quality or recommendations on PAC use, nor will they receive additional equipment or outdoor AQI alerts. They will receive PurpleAir sensors without an AQI light that are for data collection purposes only, and they will not have access to the data throughout the study. Control participants will use and maintain the PACs at their own discretion. At the end of their participation, they will have the option of receiving the additional AIRWISE components. |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 55-79 years of age one primary residence (5+ days per week)
- have an electronic device, email address, and reliable internet at home for survey submission
Key exclusion criteria (4 listed)
- current smoking of any kind or living in a household with someone who currently smokes
- current use of a portable air cleaner unit at home
- plans to move in the next year
- previous physician-diagnosed cardiovascular disease (coronary heart disease [myocardial infarction], stroke, or heart failure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE)The AIRWISE intervention consists of a 3-pronged approach grounded in the Health Belief Model (HBM) to improve residential indoor air quality through education, equipment, and behavioral cues. To reinforce cues to action, AIRWISE uses alerts from air quality sensors, prompting timely behavioral responses. Specifically, indoor and outdoor air quality alerts act as behavioral cues to promote active engagement and reference a decision matrix with specific recommendations based indoor and outdoor air quality. Recommendations on the decision matrix include simple strategies to reduce air pollution exposures, including increasing use and fan speed of portable air cleaners, opening or closing windows to change ventilation, and changing activities such as physical activity, cooking, and cleaning. This integrated approach promotes sustained behavior change by aligning with all key HBM constructs. | Behavioural | AIRWISE Intervention |
| Portable Air Cleaner (PAC) ControlParticipants will use two PACs in their home according to manufacturer recommendations. PAC Control group participants will not receive further education on air quality or recommendations on PAC use, nor will they receive additional equipment or outdoor AQI alerts. Control participants will use and maintain the PACs at their own discretion. | Other | PAC Control |
Primary outcome
Predicting Risk of CVD EVENTs (PREVENT) Score
Time frame: 0, 6, 12 months
Validated cardiovascular disease (CVD) risk score called Predicting Risk of CVD EVENTs (PREVENT). The score is a percentage ranging from 0 to 100 that indicates percentage risk of developing CVD, with higher scores indicating higher risk of developing CVD.
18 secondary outcomes
Life's Essential 8 (LE8) Score
Time frame: 0, 6, 12 months
Indoor PM2.5
Time frame: Continuous at 2-minute intervals
Indoor VOCs
Time frame: Continuous at 2-minute intervals
Glycated hemoglobin
Time frame: 0, 6, 12 months
Estimated Glomerular Filtration Rate
Time frame: 0, 6, 12 months
Total cholesterol
Time frame: 0, 6, 12 months
HDL cholesterol
Time frame: 0, 6, 12 months
LDL cholesterol
Time frame: 0, 6, 12 months
CRP
Time frame: 0, 6, 12 months
ESR
Time frame: 0, 6, 12 months
Uric acid
Time frame: 0, 6, 12 months
CBC
Time frame: 0, 6, 12 months
Systolic and diastolic blood pressure
Time frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Health symptoms
Time frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Physical activity
Time frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Sleep quality
Time frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Diet
Time frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
BMI
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE) in people with Cardiovascular Diseases and Blood Pressure, run by University of Montana at 1 site in United States.
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 2 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: opening soon, as of the sponsor's last update on 20 Apr 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 United States. 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 Ethan S Walker, PhD (406-243-2063, ethan.walker@umontana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicting Risk of CVD EVENTs (PREVENT) Score (time frame: 0, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.