Clinical trial NCT06671067: Noninvasive Assessment of Pulmonary Fluid Levels by Remote Dielectric Sensing Technology to Improve Cardiac InsUfficieney During Ischemia-Reperfusion and Clinical Outcomes in MyocArdiaL Infarction
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction
Acute Decompensated Heart Failure (ADHF)
Keywords: Remote dielectric sensing system
Acute myocardial infarction
Acute heart failure
Clinical outcomes
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 outcomes:
measure: Major adverse cardiac event (MACE)
timeFrame: 1 year
Secondary outcomes:
measure: All-cause death
timeFrame: 1 year
measure: HF readmission
timeFrame: 1 year
measure: The length of hospital readmission stay
timeFrame: 30 days
measure: Quality of life (QOL)
timeFrame: 1 year
Other outcomes:
measure: Changes in BNP levels
timeFrame: 30 days
measure: Changes in NYHA functional class
timeFrame: 30 days
Locations:
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yidong Wei, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: