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Using Indoor Air Filtration to Slow Atherothrombosis Progression in Adults With Ischemic Heart Disease History (SAPIA)

Primary Purpose

Air Pollution, Atherosclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HEPA filtration
Sham filtration
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Air Pollution focused on measuring Air pollution, Particulate matter, Air purifier, HEPA filter, Atherosclerosis, Ischemic Heart Disease, Thrombosis, Cardiovascular Disease

Eligibility Criteria

65 Years - 84 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 65 and 84 years old; Weight ≥ 110 pounds; Nonsmokers for at least 1 year; Have ischemic heart disease history, clinically stable for 6 months, without any deterioration in symptoms or episodes of angina based on past electronic medical records; Both English and Spanish speaking participants will be included in the recruitment; Live in the Los Angeles County. Exclusion Criteria: Have history of degenerative disease of the nervous system such as dementia and Alzheimer's; Currently have active cancer treatments; The residential house has already had HEPA filters; Participants will move out from the current residential address in the next 2 years; Participants will spend more than 1 month living outside the primary home; Have any health conditions that prohibit collecting health and covariate data and biospecimens; Participants' residential houses are not feasible for setting up air purifiers and air pollutants monitors.

Sites / Locations

  • Keck School of Medicine, University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HEPA first and sham

Sham first and HEPA

Arm Description

This group of participants will be assigned to the intervention of HEPA filtration with the capacity to reduce indoor PM2.5 levels at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to sham filters (air purifier has the same appearance but HEPA filter is removed) for 9 months.

This group of participants will be assigned to the intervention of sham filtration with HEPA filter removed at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to the HEPA filtration for 9 months.

Outcomes

Primary Outcome Measures

Change in blood pressure
Differences between baseline and systolic and diastolic blood pressure measured during and after intervention
Change in carotid-femoral pulse wave velocity
Differences between baseline and carotid-femoral pulse wave velocity measured with Vicorder device during and after intervention
Change in augmentation index
Differences between baseline and augmentation index measured with Vicorder device during and after intervention
Change in von Willebrand factor
Differences between baseline and von Willebrand factor measured during and after intervention
Change in P-selectin
Differences between baseline and P-selectin measured during and after intervention

Secondary Outcome Measures

Change in fasting glucose
Differences between baseline and fasting glucose measured during and after intervention
Change in fasting insulin
Differences between baseline and fasting insulin measured during and after intervention
Changes in lipid profiles
Differences between baseline and low-density lipoprotein, high-density lipoprotein, very-low-density lipoprotein, triglycerides, and total cholesterol levels measured during and after intervention
Change in C-reactive protein
Differences between baseline and C-reactive protein measured during and after intervention
Change in interleukin 6
Differences between baseline and interleukin 6 measured during and after intervention
Changes in 384 kinds of targeted cardiovascular disease-related proteomic markers
Differences between baseline and the relative abundance of 384 kinds of targeted cardiovascular disease-related proteomic markers, such as tumor necrosis factor, E-selectin, intercellular adhesion molecule 1, vascular cell adhesion molecule 1, and leptin, measured with Olink's Explore 384 cardiometabolic panel 1 during and after intervention. The Olink kit is a relative quantification assay and there are no units for the measurements.

Full Information

First Posted
April 23, 2023
Last Updated
September 22, 2023
Sponsor
University of Southern California
Collaborators
Duke University, National Institute of Environmental Health Sciences (NIEHS)
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1. Study Identification

Unique Protocol Identification Number
NCT05867381
Brief Title
Using Indoor Air Filtration to Slow Atherothrombosis Progression in Adults With Ischemic Heart Disease History
Acronym
SAPIA
Official Title
Slowing Atherothrombosis Progression Through Indoor Air Filtration: A Crossover Trial in Hispanic and Non-Hispanic Adults With Ischemic Heart Disease History
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Duke University, National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This double-blind, randomized, crossover trial aims to test the hypothesis that longer-term indoor air filtration intervention can slow atherothrombosis progression by reducing indoor fine particulate matter (PM2.5) exposure in adults with ischemic heart disease history.
Detailed Description
This double-blind, randomized, crossover trial will recruit 112 adults with ischemic heart disease history and will investigate potential benefits of indoor high efficiency particulate air (HEPA) filtration on ameliorating the progression of atherothrombosis. Participants will be contacted and recruited to the study based on inclusion and exclusion criteria. After consenting, participants will go through a total of 21-month study period comprised of true HEPA filtration and sham filtration, each of 9-month in duration, and a 3-month wash-out period. After 3-month wash-out period, participants will be switched to the other arm of the intervention. During the trial, project specialists will complete a series of home visits before, in the middle, and after each intervention session to set up air purifiers and indoor and outdoor air pollution monitors, as well as conduct interview to collect questionnaire data, measure vascular function, blood pressure, and collect biospecimens. Participants will self-monitor their daily blood pressure through out the intervention periods. In aim 1, researchers will assess the effect of a 9-month residential HEPA intervention on atherothrombosis progression in 112 participants. In aim 2, the researchers will examine the association between reduction in indoor PM2.5 exposure brought by the intervention and the changes in atherothrombosis progression indicators adjusting for outdoor PM2.5 exposure. In aim 3, researchers will examine atherothrombosis responses (both levels and slopes of change) to the HEPA intervention within four subgroups of participants: 1) non-Hispanics, 2) Hispanics, 3) females, and 4) males.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Air Pollution, Atherosclerosis
Keywords
Air pollution, Particulate matter, Air purifier, HEPA filter, Atherosclerosis, Ischemic Heart Disease, Thrombosis, Cardiovascular Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
A sham filter will be used in the control, to replace HEPA filter in the intervention group. Participants and investigators will be blinded to the intervention type, only investigators who will prepare air filters for intervention will be unblinded for the real air filter type.
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HEPA first and sham
Arm Type
Experimental
Arm Description
This group of participants will be assigned to the intervention of HEPA filtration with the capacity to reduce indoor PM2.5 levels at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to sham filters (air purifier has the same appearance but HEPA filter is removed) for 9 months.
Arm Title
Sham first and HEPA
Arm Type
Experimental
Arm Description
This group of participants will be assigned to the intervention of sham filtration with HEPA filter removed at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to the HEPA filtration for 9 months.
Intervention Type
Device
Intervention Name(s)
HEPA filtration
Intervention Description
HEPA filters with the capacity to reduce PM2.5 levels
Intervention Type
Device
Intervention Name(s)
Sham filtration
Intervention Description
Sham filtration use the same appearance of air purifier but with HEPA filter removed.
Primary Outcome Measure Information:
Title
Change in blood pressure
Description
Differences between baseline and systolic and diastolic blood pressure measured during and after intervention
Time Frame
Blood pressure will be monitored daily during each of the 9-month intervention
Title
Change in carotid-femoral pulse wave velocity
Description
Differences between baseline and carotid-femoral pulse wave velocity measured with Vicorder device during and after intervention
Time Frame
At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Title
Change in augmentation index
Description
Differences between baseline and augmentation index measured with Vicorder device during and after intervention
Time Frame
At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Title
Change in von Willebrand factor
Description
Differences between baseline and von Willebrand factor measured during and after intervention
Time Frame
At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Title
Change in P-selectin
Description
Differences between baseline and P-selectin measured during and after intervention
Time Frame
At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Secondary Outcome Measure Information:
Title
Change in fasting glucose
Description
Differences between baseline and fasting glucose measured during and after intervention
Time Frame
At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Title
Change in fasting insulin
Description
Differences between baseline and fasting insulin measured during and after intervention
Time Frame
At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Title
Changes in lipid profiles
Description
Differences between baseline and low-density lipoprotein, high-density lipoprotein, very-low-density lipoprotein, triglycerides, and total cholesterol levels measured during and after intervention
Time Frame
At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Title
Change in C-reactive protein
Description
Differences between baseline and C-reactive protein measured during and after intervention
Time Frame
At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Title
Change in interleukin 6
Description
Differences between baseline and interleukin 6 measured during and after intervention
Time Frame
At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Title
Changes in 384 kinds of targeted cardiovascular disease-related proteomic markers
Description
Differences between baseline and the relative abundance of 384 kinds of targeted cardiovascular disease-related proteomic markers, such as tumor necrosis factor, E-selectin, intercellular adhesion molecule 1, vascular cell adhesion molecule 1, and leptin, measured with Olink's Explore 384 cardiometabolic panel 1 during and after intervention. The Olink kit is a relative quantification assay and there are no units for the measurements.
Time Frame
At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 65 and 84 years old; Weight ≥ 110 pounds; Nonsmokers for at least 1 year; Have ischemic heart disease history, clinically stable for 6 months, without any deterioration in symptoms or episodes of angina based on past electronic medical records; Both English and Spanish speaking participants will be included in the recruitment; Live in the Los Angeles County. Exclusion Criteria: Have history of degenerative disease of the nervous system such as dementia and Alzheimer's; Currently have active cancer treatments; The residential house has already had HEPA filters; Participants will move out from the current residential address in the next 2 years; Participants will spend more than 1 month living outside the primary home; Have any health conditions that prohibit collecting health and covariate data and biospecimens; Participants' residential houses are not feasible for setting up air purifiers and air pollutants monitors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhanghua Chen, PhD
Phone
323-442-2109
Email
zhanghuc@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Junfeng Zhang, PhD
Phone
919-681-7782
Email
junfeng.zhang@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanghua Chen, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Junfeng Zhang, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck School of Medicine, University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanghua Chen, PhD
Phone
323-442-2109
Email
zhanghuc@usc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using Indoor Air Filtration to Slow Atherothrombosis Progression in Adults With Ischemic Heart Disease History

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