AtherosclerosisNCT06261606
Feasibility of a Multifaceted Program to Reduce Cardiovascular Complications of Air Pollution
A study testing Hybrid strategy in people with Atherosclerosis and Coronary Artery Disease, run by Parham Sadeghipour at 1 site in Iran.
Trial summary
The main goal of this clinical trial is to evaluate the feasibility of conducting a large-scale clinical trial testing a program containing several aspects for reducing the effects of air pollution on cardiovascular health (which is named the hybrid program hereafter) in adult patients (18 years or older) with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Coronary Artery Disease, Peripheral Arterial Disease
- What is being tested?
- Hybrid strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 28 Jan 2024to Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) with documented ASCVD defined as at least one of the following:
- Coronary artery disease (CAD):
- Previous or recent documented type I myocardial infarction
- History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
- History of obstructive CAD (>50% stenosis) documented by coronary computed tomography (CT) or conventional angiography
- Peripheral arterial disease (PAD):
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- Previous or recent acute ischemic limb event (>7 days prior)
- History of previous endovascular/surgical lower or upper extremities revascularization for an atherosclerotic cause
- History of ulcer or lower extremities amputation due to ASCVD.
- Carotid arterial diseases:
- History of previous endovascular/surgical carotid artery revascularization for atherosclerotic cause
- History of > 50% carotid artery stenosis based on documented imaging tests (Duplex ultrasonography, CT angiography, magnetic resonance angiography, or conventional angiography)
- Ischemic stroke:
- History of recent or previous documented ischemic stroke not due to systemic hypoperfusion/hypotension being treated with low-dose aspirin
- Willing to participate and able to provide written informed consent
Who cannot join
- Being within 7 days of acute/unstable ASCVD events (acute myocardial infarction, acute limb event, and acute ischemic stroke) or receiving triple antithrombotic therapy
- Active bleeding
- History of upper gastrointestinal bleeding within the past 30 days
- History of intracranial hemorrhage within the past 30 days
- End-stage kidney disease with estimated creatinine clearance < 15 mL/min, or undergoing hemodialysis or peritoneal dialysis
- Known aspirin sensitivity without prior successful desensitization
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- Known comorbidities associated with poor prognosis (e.g., metastatic cancer) in conjunction with an estimated life expectancy of less than one year according to the treating clinician
- Vascular disease known exclusively to be from causes other than atherosclerosis (spontaneous coronary or peripheral dissection (fibromuscular dysplasia, segmental arterial mediolysis) or vasculitis such as Takayasu arteritis, Buerger's disease (i.e., thromboangiitis obliterans), and Churg Strauss syndrome
- Inherited or acquired severe coagulopathies including hemophilia and decompensated liver cirrhosis
- Any other unexpected/unwarranted conditions that make the participants unsuitable for recruitment or follow-up
- Known allergy to KN-95 or other masks, or citrus fruits
- Any facial dysmorphia that makes the patient unable or unwilling to wear a face mask
- Any medical condition necessitating unblinded facemask use for outdoor activities at the discretion of the treating clinician, or based on patient preference
- Inability to receive/read text messages/phone calls by personal mobile phone
- Unwillingness to participate, such as hesitation to wear a mask, if randomized
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Rajaie Cardiovascular Medical and Research Center
Tehran, 1995614331
Parham Sadeghipour, MD, +98 21 2392 2092, psadeghipour@rhc.ac.ir
About this study
Official title: Feasibility of a Multifaceted Intervention to Mitigate the Cardiovascular Adverse Effects of Air Pollution: The COATED-AIR Feasibility Trial
The main goal of this clinical trial is to evaluate the feasibility of conducting a large-scale clinical trial testing a program containing several aspects for reducing the effects of air pollution on cardiovascular health (which is named the hybrid program hereafter) in adult patients (18 years or older) with atherosclerotic cardiovascular disease. Furthermore, we seek to answer how much patients adhere to and are satisfied with implementing the hybrid program, and what problems executing this program will bring for patients.
Read the detailed description
Background:
Air pollution, as the fourth leading cause of mortality globally, is annually responsible for 6.67 million deaths worldwide and approximately half of them are attributable to cardiovascular causes. Some of the pollutants can negatively affect the cardiovascular system, as they may pass through the lungs, entering into the bloodstream, and cause inflammation and oxidative stress. Exposure to these pollutants is associated with a diverse range of fatal and/or adverse non-fatal cardiovascular events, including myocardial infarction, heart failure, atrial fibrillation, and ischemic stroke.
Besides strategies in societal-level aiming to control the air pollution, various individual-level solutions have been suggested to mitigate the health-related effects of air pollution. Text messaging via mobile phones to alert individuals about unhealthy air quality levels, and recommending to limit activity and time spent in outdoors, use face mask when going out, or use air filtration systems are among these individual-level solutions to restrict the air pollution-related health effects. Furthermore, several studies have proposed dietary interventions and demonstrated that some nutrients, especially vitamins C and E, are potentially capable to counter with the adverse effects of air pollutants on the cardiovascular system. However, the efficacy of these individual-level solutions to reduce the the incidence of clinically relevant outcomes such as myocardial infarction, stroke, and acute limb events.
The current pilot randomized controlled trial (RCT) seeks to test the feasibility and adherence of patients with atherosclerotic cardiovascular diseases (ASCVD) to a multifaceted intervention including a one-page informational flashcard, cell phone message alerting on days with poor air quality to encourage patients not to spend time outdoors, or to wearing KN-95 facemasks outdoors in those days, and encouraging patients to consume citrus fruits on highly polluted days (which is hereafter referred to as hybrid strategy).
Randomization Procedure:
Single-center (Rajaie Cardiovascular Medical and Research Center) open-label randomized controlled trial with a 1:1 allocation ratio to hybrid strategy versus control. Permuted block randomization with block sizes of four via a web-based system will be used for the study. The specifications for the generation of the randomization schedule will be prepared by the study biostatistician. For this study, the randomization schedule refers to a list that includes the subject identification number, randomization block number, randomization code, and the allocated treatment. Such data will be kept confidential and not shared with clinical coordinators, the Steering Committee, or other trial staff members.
Outcome assessment:
The outcomes will be adjudicated by the Steering Committee, blinded to the assigned intervention
Statistical Considerations:
A convenience sample size of 50 patients (25 in the intervention arm and 25 in the control arm) is considered for this feasibility trial without power calculation for hypothesis testing. Categorical variables will be summarized as counts, percentages, and corresponding 95% confidence intervals, and will be compared between intervention and control arms using the chi-squared test. Normally distributed continuous variables will be presented as mean ± standard deviation and will be compared using the independent samples T-test. Non-normally distributed continuous variables will be expressed as median and interquartile range and will be compared using the Mann-Whitney U test. Hypothesis testing, if performed, will be for the purpose of hypothesis generation.
- Conditions
- Atherosclerosis, Coronary Artery Disease, Peripheral Arterial Disease, Ischemic Stroke, Carotid Artery Diseases
- Being tested
- Hybrid strategy
- Keywords
- Air Pollution, Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Myocardial Infarction, Peripheral Arterial Disease, Ischemic Stroke, Carotid Artery Diseases, KN-95 mask
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Peripheral Arterial Disease, Ischemic Stroke, Carotid Artery Diseases, Cardiovascular Diseases, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid strategyOther
A hybrid strategy inclusive of:
- A one-page flashcard describing the adverse cardiovascular effects of air pollution and individual-level strategies to mitigate these effects
- Alerting patients on polluted days (defined as air quality index (AQI) ≥ 131 [33]) by sending cell phone text messages and recommending to not go outdoors or minimize outdoor activities (especially exercising) on those days. This will also be accompanied by periodic phone calls to ascertain that the patients receive the messages and are attentive to them.
- Wearing KN-95 facemasks (provided by the investigators of this study) as a physical barrier against air pollution on highly polluted days (defined as AQI ≥ 131) in case the patient cannot avoid going outdoors
- Dietary intervention by encouraging patients to consume citrus fruits during days with AQI ≥ 131
| Study group | Role | What they receive |
|---|---|---|
| Hybrid strategy | Experimental | A hybrid strategy inclusive of:
1. A one-page flashcard describing the adverse cardiovascular effects of air pollution and individual-level strategies to mitigate these effects
2. Alerting patients on polluted days (defined as air quality index (AQI) ≥ 131 [33]) by sending cell phone text messages and recommending to not go outdoors or minimize outdoor activities (especially exercising) on those days. This will also be accompanied by periodic phone calls to ascertain that the patients receive the messages and are attentive to them.
3. Wearing KN-95 facemasks (provided by the investigators of this study) as a physical barrier against air pollution on highly polluted days (defined as AQI ≥ 131) in case the patient cannot avoid going outdoors
4. Dietary intervention by encouraging patients to consume citrus fruits during days with AQI ≥ 131. Receives: Other: Hybrid strategy |
| Usual care | No intervention | No active strategy (usual care) without any clear recommendations related to air pollution. A control card will be shared with the patients randomized to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting the trial
Recruitment rate defined as the proportion of participants randomized divided by the proportion of eligible participants
Measured: within 30 days
Secondary outcomes (3)
Adherence to the individual components of the hybrid strategy
Adherence to any individual recommendations of the educational flashcards for mitigating the cardiovascular adverse effects of air pollution, including avoidance from going outdoors on polluted days as stated by text messaging, or wearing KN-95 facemasks if going outdoors on those days, and the dietary recommendations regarding the daily consumption of citrus fruits on highly polluted days during the 30-day follow-up. This outcome will be assessed using a custom-made questionnaire in the intervention group
Measured: within 30 days
Patient satisfaction with the hybrid strategy
This outcome will be assessed using a custom-made 6-question questionnaire in only the intervention group, through a 5-point Likert scale for every question (1 to 5 points) with higher scores indicating better satisfaction (range= 6-30).
Measured: within 30 days
Any potential adverse events in intervention and control groups during the 30-day follow-up
severe mask-related skin reactions, mortality (cardiovascular and non-cardiovascular), hospitalization due to cardiorespiratory causes, myocardial infarction, ischemic stroke, acute limb events, major amputation, unplanned arterial revascularization, dyspepsia and peptic ulcer disease, gastrointestinal bleeding, and major and clinically-relevant nonmajor bleeding according to International Society on Thrombosis and Haemostasis (ISTH) criteria
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start28 Jan 2024
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants undergo permuted block randomization with block sizes of four via a web-based system will be used for the study, in a 1:1 ratio between the hybrid strategy or control arms.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parham Sadeghipour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Parham Sadeghipour, Rajaie Cardiovascular Medical and Research Center
- Investigators
- Parham Sadeghipour, M.D, Principal investigator, Rajaie Cardiovascular Medical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261606
- Sponsor's protocol ID
- 4020286
- Status last verified
- Mar 2024
- First submitted
- 7 Feb 2024
- Last updated
- 5 Mar 2024
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Multifaceted Intervention to Mitigate the Cardiovascular Adverse Effects of Air Pollution: The COATED-AIR Feasibility Trial
- ClinicalTrials.gov ID
- NCT06261606
- Acronym / sponsor ID
- 4020286
- Conditions
- Atherosclerosis, Coronary Artery Disease, Peripheral Arterial Disease, Ischemic Stroke, Carotid Artery Diseases
- Keywords
- Air Pollution, Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Myocardial Infarction, Peripheral Arterial Disease, Ischemic Stroke, Carotid Artery Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Parham SadeghipourUniversity, hospital or other
- Study start
- 28 Jan 2024 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 15 Feb 2024 (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.
The main goal of this clinical trial is to evaluate the feasibility of conducting a large-scale clinical trial testing a program containing several aspects for reducing the effects of air pollution on cardiovascular health (which is named the hybrid program hereafter) in adult patients (18 years or older) with atherosclerotic cardiovascular disease. Furthermore, we seek to answer how much patients adhere to and are satisfied with implementing the hybrid program, and what problems executing this program will bring for patients.
Detailed description
Background:
Air pollution, as the fourth leading cause of mortality globally, is annually responsible for 6.67 million deaths worldwide and approximately half of them are attributable to cardiovascular causes. Some of the pollutants can negatively affect the cardiovascular system, as they may pass through the lungs, entering into the bloodstream, and cause inflammation and oxidative stress. Exposure to these pollutants is associated with a diverse range of fatal and/or adverse non-fatal cardiovascular events, including myocardial infarction, heart failure, atrial fibrillation, and ischemic stroke.
Besides strategies in societal-level aiming to control the air pollution, various individual-level solutions have been suggested to mitigate the health-related effects of air pollution. Text messaging via mobile phones to alert individuals about unhealthy air quality levels, and recommending to limit activity and time spent in outdoors, use face mask when going out, or use air filtration systems are among these individual-level solutions to restrict the air pollution-related health effects. Furthermore, several studies have proposed dietary interventions and demonstrated that some nutrients, especially vitamins C and E, are potentially capable to counter with the adverse effects of air pollutants on the cardiovascular system. However, the efficacy of these individual-level solutions to reduce the the incidence of clinically relevant outcomes such as myocardial infarction, stroke, and acute limb events.
The current pilot randomized controlled trial (RCT) seeks to test the feasibility and adherence of patients with atherosclerotic cardiovascular diseases (ASCVD) to a multifaceted intervention including a one-page informational flashcard, cell phone message alerting on days with poor air quality to encourage patients not to spend time outdoors, or to wearing KN-95 facemasks outdoors in those days, and encouraging patients to consume citrus fruits on highly polluted days (which is hereafter referred to as hybrid strategy).
Randomization Procedure:
Single-center (Rajaie Cardiovascular Medical and Research Center) open-label randomized controlled trial with a 1:1 allocation ratio to hybrid strategy versus control. Permuted block randomization with block sizes of four via a web-based system will be used for the study. The specifications for the generation of the randomization schedule will be prepared by the study biostatistician. For this study, the randomization schedule refers to a list that includes the subject identification number, randomization block number, randomization code, and the allocated treatment. Such data will be kept confidential and not shared with clinical coordinators, the Steering Committee, or other trial staff members.
Outcome assessment:
The outcomes will be adjudicated by the Steering Committee, blinded to the assigned intervention
Statistical Considerations:
A convenience sample size of 50 patients (25 in the intervention arm and 25 in the control arm) is considered for this feasibility trial without power calculation for hypothesis testing. Categorical variables will be summarized as counts, percentages, and corresponding 95% confidence intervals, and will be compared between intervention and control arms using the chi-squared test. Normally distributed continuous variables will be presented as mean ± standard deviation and will be compared using the independent samples T-test. Non-normally distributed continuous variables will be expressed as median and interquartile range and will be compared using the Mann-Whitney U test. Hypothesis testing, if performed, will be for the purpose of hypothesis generation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants undergo permuted block randomization with block sizes of four via a web-based system will be used for the study, in a 1:1 ratio between the hybrid strategy or control arms.
| Arm | Type | Receives |
|---|---|---|
| Hybrid strategy | Experimental | Other: Hybrid strategyA hybrid strategy inclusive of: 1. A one-page flashcard describing the adverse cardiovascular effects of air pollution and individual-level strategies to mitigate these effects 2. Alerting patients on polluted days (defined as air quality index (AQI) ≥ 131 [33]) by sending cell phone text messages and recommending to not go outdoors or minimize outdoor activities (especially exercising) on those days. This will also be accompanied by periodic phone calls to ascertain that the patients receive the messages and are attentive to them. 3. Wearing KN-95 facemasks (provided by the investigators of this study) as a physical barrier against air pollution on highly polluted days (defined as AQI ≥ 131) in case the patient cannot avoid going outdoors 4. Dietary intervention by encouraging patients to consume citrus fruits during days with AQI ≥ 131. |
| Usual care | No intervention | –No active strategy (usual care) without any clear recommendations related to air pollution. A control card will be shared with the patients randomized to the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult patients (≥18 years) with documented ASCVD defined as at least one of the following:
- Willing to participate and able to provide written informed consent
Key exclusion criteria (15 listed)
- Being within 7 days of acute/unstable ASCVD events (acute myocardial infarction, acute limb event, and acute ischemic stroke) or receiving triple antithrombotic therapy
- Active bleeding
- History of upper gastrointestinal bleeding within the past 30 days
- History of intracranial hemorrhage within the past 30 days
- End-stage kidney disease with estimated creatinine clearance < 15 mL/min, or undergoing hemodialysis or peritoneal dialysis
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 |
|---|---|---|
| Hybrid strategyA hybrid strategy inclusive of: 1. A one-page flashcard describing the adverse cardiovascular effects of air pollution and individual-level strategies to mitigate these effects 2. Alerting patients on polluted days (defined as air quality index (AQI) ≥ 131 [33]) by sending cell phone text messages and recommending to not go outdoors or minimize outdoor activities (especially exercising) on those days. This will also be accompanied by periodic phone calls to ascertain that the patients receive the messages and are attentive to them. 3. Wearing KN-95 facemasks (provided by the investigators of this study) as a physical barrier against air pollution on highly polluted days (defined as AQI ≥ 131) in case the patient cannot avoid going outdoors 4. Dietary intervention by encouraging patients to consume citrus fruits during days with AQI ≥ 131 | Other | Hybrid strategy |
Primary outcome
Feasibility of conducting the trial
Time frame: within 30 days
Recruitment rate defined as the proportion of participants randomized divided by the proportion of eligible participants
3 secondary outcomes
Adherence to the individual components of the hybrid strategy
Time frame: within 30 days
Patient satisfaction with the hybrid strategy
Time frame: within 30 days
Any potential adverse events in intervention and control groups during the 30-day follow-up
Time frame: within 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Parham Sadeghipour, M.D principal investigator
Rajaie Cardiovascular Medical and Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid strategy in people with Atherosclerosis and Coronary Artery Disease, run by Parham Sadeghipour at 1 site in Iran.
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 15 inclusion and 15 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 5 Mar 2024. 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 Iran. 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 Parham Sadeghipour, MD (+989121454319, psadeghipour@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of conducting the trial (time frame: within 30 days). 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 5 Mar 2024.