Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06261606 |
Other study ID # |
4020286 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 28, 2024 |
Est. completion date |
March 2024 |
Study information
Verified date |
March 2024 |
Source |
Rajaie Cardiovascular Medical and Research Center |
Contact |
Parham Sadeghipour, MD |
Phone |
+989121454319 |
Email |
psadeghipour[@]hotmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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.
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.