NCT06671067

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Nov 2024Jun 2027

First Submitted

Initial submission to the registry

October 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

2.2 years

First QC Date

October 29, 2024

Last Update Submit

October 31, 2024

Conditions

Acute Myocardial InfarctionAcute Decompensated Heart Failure (ADHF)

Keywords

Remote dielectric sensing systemAcute myocardial infarctionAcute heart failureClinical outcomes

Outcome Measures

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.

    1 year

Secondary Outcomes (4)

  • All-cause death

    1 year

  • HF readmission

    1 year

  • The length of hospital readmission stay

    30 days

  • Quality of life (QOL)

    1 year

Other Outcomes (2)

  • Changes in BNP levels

    30 days

  • Changes in NYHA functional class

    30 days

Study Arms (2)

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

Device: Remote dielectric sensing system

Interventions

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.

ReDS-guided care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Huaihe Hospital of Henan University

Kaifeng, Henan, China

Location

Kaifeng Central Hospital

Kaifeng, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine Shanghai

Shanghai, Shanghai Municipality, China

Location

Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Study Officials

  • Yidong Wei, M.D., Ph.D.

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yidong Wei, M.D., Ph.D.

CONTACT

+86-18917683409ywei@tongji.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

October 29, 2024

First Posted

November 4, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

November 4, 2024

Record last verified: 2024-10

Locations

CN(6)