Feasibility of a Multifaceted Program to Reduce Cardiovascular Complications of Air Pollution

NCT06261606 | Recruiting DMC

• 1 other identifier: 4020286
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

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; KN-95 mask

Outcome Measures

Primary Outcomes (1)

• Feasibility of conducting the trial

  Recruitment rate defined as the proportion of participants randomized divided by the proportion of eligible participants

  within 30 days

Secondary Outcomes (3)

• Adherence to the individual components of the hybrid strategy

  within 30 days

• Patient satisfaction with the hybrid strategy

  within 30 days

• Any potential adverse events in intervention and control groups during the 30-day follow-up

  within 30 days

Other Outcomes (2)

• Change in the health-related quality of life

  within 30 days

• Change in the level of anxiety

  within 30 days

Study Arms (2)

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.

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

Interventions

Hybrid strategy OTHER

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

Hybrid strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Parham Sadeghipour: lead

Study Sites (1)

Rajaie Cardiovascular Medical and Research Center

Tehran, 1995614331, Iran

RECRUITING

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Peripheral Arterial Disease; Ischemic Stroke; Carotid Artery Diseases; Cardiovascular Diseases; Myocardial Infarction

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Peripheral Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Parham Sadeghipour, M.D

  Rajaie Cardiovascular Medical and Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Parham Sadeghipour, MD

CONTACT

+989121454319; psadeghipour@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: January 28, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)