Short-term Cardiovascular Benefits of Wearing Particulate-filtering Respirators

NCT02238028 | Completed Results DMC

• 1 other identifier: KZGY 001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

An intervention study to assess the short-term cardiovascular effects of reducing personal air pollution exposure by wearing particulate filtering respirators.

Conditions

Autonomic Nervous System Imbalance; Blood Pressure; Inflammation; Vasoconstriction; Blood Coagulation Disorders

Keywords

Heart rate variability; Blood pressure; Circulating biomarkers; Respirator; Fine particulate matter

Outcome Measures

Primary Outcomes (8)

• Heart Rate Variability-LF Power,HF Power,VLF Power

  HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.

  up to 24 hours

• Blood Pressure

  The blood pressure were measured by automatic blood pressure monitor during the intervention study.

  up to 24 hours

• Heart Rate Variability-SDNN,SDANN, rMSSD

  HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention.

  Up to 24 hours

• Heart Rate Variability-LF/HF

  HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.

  Up to 24 hours

• Heart Rate Variability-pNN50

  HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention.

  Up to 24 hours

• Circulating Biomarkers--Fibrinogen，vWF

  At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)

  Up to 24 hours

• Circulating Biomarkers--P- Selectin,VCAM-1

  At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)

  Up to 24 hours

• Circulating Biomarkers--ET-1

  At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays.

  Up to 24 hours

Study Arms (2)

Wear respirator

EXPERIMENTAL

The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.

Behavioral: Wear respirator

Not wear respirator

NO INTERVENTION

The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.

Interventions

Wear respirator BEHAVIORAL

Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.

Also known as: particulate filtering respirator

Wear respirator

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Equal to or older than 18 years old,
• No history of smoking and alcohol addiction.
• No chronic diseases,such as hypertension,diabetes,chronic obstructive pulmonary disease or other respiratory/cardiovascular diseases reported by volunteers.
• No respiratory or allergic diseases, like asthma, rhinitis,or other allergic diseases.

You may not qualify if:

• Current smokers
• Chronic drug use due on cardiovascular or respiratory diseases

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

• Shah AS, Langrish JP, Nair H, McAllister DA, Hunter AL, Donaldson K, Newby DE, Mills NL. Global association of air pollution and heart failure: a systematic review and meta-analysis. Lancet. 2013 Sep 21;382(9897):1039-48. doi: 10.1016/S0140-6736(13)60898-3. Epub 2013 Jul 10.

  PMID: 23849322 BACKGROUND

• Chen R, Zhao A, Chen H, Zhao Z, Cai J, Wang C, Yang C, Li H, Xu X, Ha S, Li T, Kan H. Cardiopulmonary benefits of reducing indoor particles of outdoor origin: a randomized, double-blind crossover trial of air purifiers. J Am Coll Cardiol. 2015 Jun 2;65(21):2279-87. doi: 10.1016/j.jacc.2015.03.553.

  PMID: 26022815 BACKGROUND

MeSH Terms

Conditions

Inflammation; Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Haidong Kan
• Organization: Fudan University

kanh@fudan.edu.cn

+86-021-54237908

Study Officials

• Kan Haidong, PhD

  School of Public Health，Fudan University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ph.D.

Study Record Dates

• First Submitted: September 7, 2014
• First Posted: September 12, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 6, 2016
• Results First Posted: May 6, 2016

Record last verified: 2016-04

Locations

CN (1)