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ClinicalTrials.gov ID

NCT06671067

Lead Sponsor

Shanghai 10th People's HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

2,000Estimated

Last Update Posted

Nov 4, 2024Actual

Start Date

Nov 1, 2024Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jun 2027Estimated

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

Brief 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.

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.

• Acute Myocardial Infarction
• Acute Decompensated Heart Failure (ADHF)

• Remote dielectric sensing system

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Shanghai 10th People's HospitalOTHER

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