Noninvasive Assessment of Pulmonary Fluid Levels by Remote Dielectric Sensing Technology to Improve Cardiac InsUfficieney During Ischemia-Reperfusion and Clinical Outcomes in MyocArdiaL Infarction (NATURAL)

October 31, 2024 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital

Noninvasive Assessment of Pulmonary Fluid Levels by Remote Dielectric Sensing (ReDS™) Technology to Improve Cardiac Insufficiency During Ischemia-reperfusion and Clinical Outcomes in Myocardial Infarction

To explore whether a ReDS-guided strategy for AMI patients with cardiac insufficiency following coronary flow reperfusion is superior to routine care for improving outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The remote dielectric sensing (ReDS) system is a non-invasive medical device that emits a low-power electromagnetic signal through the chest and lungs, which can accurately measure changes in lung fluid concentration. Previous studies suggest that ReDS-guided management may have the potential role in the diagnosis and treatment of acute heart failure (AHF): (1) Assessment of real-time volume status: Patients with AHF are often accompanied by volume overload, especially pulmonary congestion, which is one of the main risk factors for readmission; (2) Establishment of treatment strategy: The ReDS-SAFE HF study showed that the AHF treatment strategy based on the ReDS measurement could significantly reduce the readmission rate and the clinical outcomes after discharge; (3) Determine time to discharge: The study ReDS-SAFE HF also suggests ReDS measurement can aid physicians to determine the appropriate time to discharge by monitoring changes in the volume of lung fluid, which can relatively avoid the risk of early or late discharge.

Acute myocardial stunning and injury combined with cardiac insufficiency is one common complication of acute myocardial infarction (AMI), the large infarcted area of the left ventricular anterior wall can lead to heart pump failure, which will cause pulmonary edema and acute decompensated heart failure (ADHF) in the long-term recovery. Although cardiomyocytes do not completely lose their activity following the cardiac circulatory reperfusion, it still requires a long period for the myocardium to restore normal function, which closely related to the basal myocardial status, number of coronary lesions, area of myocardial infarction, and time of reperfusion. Long-time loss of myocardial activity then results in irreversible myocardial remodeling of patients in and seriously impacts the life quality of life of AMI patients. Therefore, it is particularly important to find an effective convenient management scheme to improve cardiac insufficiency following ischemic reperfusion in AMI patients. Among these patients, acute ischemic myocardium and cardiac dysfunction could simultaneously induce rapid adaptive alterations in lung fluid, which provides an indicative parameter in the clinical and could be well-determined by the ReDS devices.

This study sought to explore whether a ReDS-guided strategy for AMI patients with cardiac insufficiency following coronary flow reperfusion is superior to routine care for improving outcomes.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Kaifeng, Henan, China
        • Kaifeng Central Hospital
        • Contact:
          • Xiaoming Qin, M.D., Ph.D.
          • Phone Number: +86-18817288086
          • Email: 912862966@qq.com
        • Contact:
          • Xiaoming Qin, M.D., Ph.D.
      • Kaifeng, Henan, China
        • Huaihe Hospital of Henan University
        • Contact:
        • Contact:
          • Keqiang Zuo, M.D., Ph.D.
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Contact:
          • Hongqiang Li, M.D, Ph.D
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai Tenth People's Hospital
        • Contact:
          • Baoxin Liu, M.D., Ph.D.
          • Phone Number: +86-18817367763
          • Email: wfboys@163.com
      • Shanghai, Shanghai, China
        • Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Contact:
          • Hou Lei, M.D., Ph.D.
      • Shanghai, Shanghai, China
        • Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine Shanghai
        • Contact:
        • Contact:
          • Shaowei Zhuang, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients were required to be aged ≥ 18 years and to be hospitalized for a primary diagnosis of AMI,
  2. AMI patients accompanied by cardiac insufficiency following coronary revascularization, which is characterized by the symptoms and signs of fluid overload, regardless of left ventricular ejection fraction (LVEF), and have an N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration of ≥ 400 pg/L or a BNP concentration of ≥ 100 pg/L.

Exclusion Criteria:

  1. Patient's physical characteristics that prevented the use of the ReDS system (height of <155 or >190 cm; body mass index of <22 or >39 kg/m2)
  2. Patients with chronic obstructive pulmonary disease or other lung diseases that might confound ReDS values
  3. Patients with a left ventricular assist device or undergoing cardiac transplantation;
  4. Patients with congenital heart malformations or intrathoracic mass that would affect right lung anatomy;
  5. Patients with end-stage renal disease on hemodialysis;
  6. Patients whose life expectancy less than 12 months due to noncardiac comorbidities
  7. Patients who participate in another randomized studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine care group
AMI patients with cardiac insufficiency following coronary revascularization who receive the routine care without ReDS guiding
Experimental: ReDS-guided care group
AMI patients with cardiac insufficiency following coronary revascularization who receive the ReDS guiding care
Device: Remote dielectric sensing system
The remote dielectric sensing (ReDS) system is a non-invasive medical device that emits a low-power electromagnetic signal through the chest and lungs, which can accurately measure changes in lung fluid concentration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac event (MACE)
Time Frame: 1 year
The primary outcome is the MACE that is defined as a composite of all-cause death and HF readmission.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: 1 year
1 year
HF readmission
Time Frame: 1 year
HF readmission was defined as a minimum of an overnight hospitalization for a patient presenting with symptoms and signs of HF or requiring intravenous diuretics
1 year
The length of hospital readmission stay
Time Frame: 30 days
The length of hospital readmission stay
30 days
Quality of life (QOL)
Time Frame: 1 year
The quality of life was assessed according to Minnesota Living with Heart Failure Questionnaire (MLHFQ). The 21 items of MLHFQ are rated on six-point Likert scales, representing different degrees of impact of HF on patient's QOL, from 0 (no) to 5 (very much). It provides a total score (range 0-105), from best to worst QOL.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in BNP levels
Time Frame: 30 days
Changes in BNP levels
30 days
Changes in NYHA functional class
Time Frame: 30 days
Changes in NYHA functional class
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Investigators

  • Principal Investigator: Yidong Wei, M.D., Ph.D., Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Estimated)

November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NATURAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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