Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | 1 year | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in BNP levels | Changes in BNP levels | 30 days |
| Changes in NYHA functional class | Changes in NYHA functional class | 30 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yidong Wei, M.D., Ph.D. | Contact | +86-18917683409 | ywei@tongji.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yidong Wei, M.D., Ph.D. | Shanghai 10th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huaihe Hospital of Henan University | Kaifeng | Henan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| The length of hospital readmission stay | The length of hospital readmission stay | 30 days |
| 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. | 1 year |
| Kaifeng Central Hospital | Kaifeng | Henan | China |
|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
|
| Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | 200072 | China |
|
| Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine Shanghai | Shanghai | Shanghai Municipality | China |
|
| Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | China |
|