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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai 10th People's Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Remote dielectric sensing system

    Device

    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.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Routine care groupNo intervention 0 interventions
Group B: ReDS-guided care groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major adverse cardiac event (MACE)

The primary outcome is the MACE that is defined as a composite of all-cause death and HF readmission.

Time frame
1 year

Secondary outcomes

1

All-cause death

Time frame
1 year
2

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

Time frame
1 year
3

The length of hospital readmission stay

The length of hospital readmission stay

Time frame
30 days
4

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.

Time frame
1 year

Other outcomes

1

Changes in BNP levels

Changes in BNP levels

Time frame
30 days
2

Changes in NYHA functional class

Changes in NYHA functional class

Time frame
30 days

Sponsors and contacts

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