Acute Myocardial InfarctionNATURALNCT06671067
Noninvasive Assessment of Pulmonary Fluid Levels by Remote Dielectric Sensing Technology to Improve Cardiac InsUfficieney During Ischemia-Reperfusion and Clinical Outcomes in MyocArdiaL Infarction
A study testing Remote dielectric sensing system in people with Acute Myocardial Infarction and Acute Decompensated Heart Failure (ADHF), run by Shanghai 10th People's Hospital at 6 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Acute Decompensated Heart Failure (ADHF)
- What is being tested?
- Remote dielectric sensing system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 6 sitesChina
- Study dates
- 1 Nov 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were required to be aged ≥ 18 years and to be hospitalized for a primary diagnosis of AMI,
- 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.
Who cannot join
- 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)
- Patients with chronic obstructive pulmonary disease or other lung diseases that might confound ReDS values
- Patients with a left ventricular assist device or undergoing cardiac transplantation;
- Patients with congenital heart malformations or intrathoracic mass that would affect right lung anatomy;
- Patients with end-stage renal disease on hemodialysis;
- Patients whose life expectancy less than 12 months due to noncardiac comorbidities
- Patients who participate in another randomized studies.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Huaihe Hospital of Henan University
Kaifeng, Henan
Keqiang Zuo, M.D., Ph.D., +86-18917684112, 18917684112@163.com
Keqiang Zuo, M.D., Ph.D.
Kaifeng Central Hospital
Kaifeng, Henan
Xiaoming Qin, M.D., Ph.D., +86-18817288086, 912862966@qq.com
Xiaoming Qin, M.D., Ph.D.
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Baoxin Liu, M.D., Ph.D., +86-18817367763, wfboys@163.com
Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine Shanghai
Shanghai, Shanghai Municipality
Shaowei Zhuang, M.D., Ph.D., Zhuangs_tcm@163.com
Shaowei Zhuang, M.D., Ph.D.
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Lei Hou, M.D., Ph.D., hl4081@shtrhospital.com
Hou Lei, M.D., Ph.D.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Hongqiang Li, M.D, Ph.D, +86-18916083927, 1610620@tongji.edu.cn
Hongqiang Li, M.D, Ph.D
About this study
Official title: 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.
Read the 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.
- Being tested
- Remote dielectric sensing system
- Keywords
- Remote dielectric sensing system, Acute myocardial infarction, Acute heart failure, Clinical outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote dielectric sensing systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine care group | No intervention | AMI patients with cardiac insufficiency following coronary revascularization who receive the routine care without ReDS guiding |
| ReDS-guided care group | Experimental | AMI patients with cardiac insufficiency following coronary revascularization who receive the ReDS guiding care Receives: Device: Remote dielectric sensing system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event (MACE)
The primary outcome is the MACE that is defined as a composite of all-cause death and HF readmission.
Measured: 1 year
Secondary outcomes (4)
All-cause death
Measured: 1 year
HF readmission
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
Measured: 1 year
The length of hospital readmission stay
The length of hospital readmission stay
Measured: 30 days
Quality of life (QOL)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yidong Wei, M.D., Ph.D., Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671067
- Sponsor's protocol ID
- NATURAL
- Acronym
- NATURAL
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06671067
- Acronym / sponsor ID
- NATURAL / NATURAL
- Keywords
- Remote dielectric sensing system, Acute myocardial infarction, Acute heart failure, Clinical outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care group | No intervention | –AMI patients with cardiac insufficiency following coronary revascularization who receive the routine care without ReDS guiding |
| ReDS-guided care group | Experimental | Device: Remote dielectric sensing systemAMI patients with cardiac insufficiency following coronary revascularization who receive the ReDS guiding care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients were required to be aged ≥ 18 years and to be hospitalized for a primary diagnosis of AMI,
- 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.
Key exclusion criteria (7 listed)
- 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)
- Patients with chronic obstructive pulmonary disease or other lung diseases that might confound ReDS values
- Patients with a left ventricular assist device or undergoing cardiac transplantation;
- Patients with congenital heart malformations or intrathoracic mass that would affect right lung anatomy;
- Patients with end-stage renal disease on hemodialysis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote dielectric sensing systemThe 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. | Device | ReDS-guided care group |
Primary outcome
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.
4 secondary outcomes
All-cause death
Time frame: 1 year
HF readmission
Time frame: 1 year
The length of hospital readmission stay
Time frame: 30 days
Quality of life (QOL)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yidong Wei, M.D., Ph.D. principal investigator
Shanghai 10th People's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote dielectric sensing system in people with Acute Myocardial Infarction and Acute Decompensated Heart Failure (ADHF), run by Shanghai 10th People's Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yidong Wei, M.D., Ph.D. (+86-18917683409, ywei@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac event (MACE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.