About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Remote dielectric sensing system
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Major adverse cardiac event (MACE)
The primary outcome is the MACE that is defined as a composite of all-cause death and HF readmission.
Secondary outcomes
All-cause death
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
The length of hospital readmission stay
The length of hospital readmission stay
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.
Other outcomes
Changes in BNP levels
Changes in BNP levels
Changes in NYHA functional class
Changes in NYHA functional class
Sponsors and contacts
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