BridgeMD
New treatment option for Shock, Cardiogenic
Official title Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock
ClinicalTrials.gov ID: NCT07085221
What this study is testing
What is hospital external management?
hospital external management is an investigational medicine, given as an once-daily, being studied as a potential treatment for shock, cardiogenic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical study was a multi-center, open-label, randomized controlled clinical trial. A total of 472 patients with early-stage cardiogenic shock were recruited and randomly divided into the experimental group and the control group, with 236 cases in each group.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years old;
- The patient meets the diagnosis of early-stage cardiogenic shock, with SCAI stage A, B, or C during hospitalization; (1) SCAI stage A: Without signs...
- Combined with extensive myocardial infarction, diagnosed as widespread anterior wall myocardial infarction based on ST-segment elevation in ECG leads...
- Concurrent acute heart failure or acute exacerbation of chronic heart failure. (2) SCAI stage B-C (meeting the following conditions) 1) 60 \ 30 mmHg...
- SBP ≥ 90 mmHg when vasoactive drugs are not used;
You likely can't join if
- Unable to use a smartphone for out-of-hospital management despite training
- The reasons for discharge were treatment withdrawal and transfer to another hospital for continued therapy
- Previous or current hospital admission due to cardiac arrest
- Refractory cardiogenic shock
- Refractory Heart Failure (ACC/AHA guidelines Stage D heart Failure)
- Left ventricular ejection fraction \< 30%
See the full eligibility criteria
- Age ≥ 18 years old;
- The patient meets the diagnosis of early-stage cardiogenic shock, with SCAI stage A, B, or C during hospitalization; (1) SCAI stage A: Without signs of shock and meeting one of the following criteria:
- Combined with extensive myocardial infarction, diagnosed as widespread anterior wall myocardial infarction based on ST-segment elevation in ECG leads (V1-V5, aVL, I leads), inferior wall combined with right ventricular...
- Concurrent acute heart failure or acute exacerbation of chronic heart failure. (2) SCAI stage B-C (meeting the following conditions) 1) 60 \ 30 mmHg from baseline lasting 30 minutes; or SBP ≥ 90 mmHg but heart rate /SBP...
- SBP ≥ 90 mmHg when vasoactive drugs are not used;
- No signs and symptoms of shock. 4. Understand and be willing to sign the informed consent, and be willing to follow the treatment and visit plan required by the protocol.
- Unable to use a smartphone for out-of-hospital management despite training
- The reasons for discharge were treatment withdrawal and transfer to another hospital for continued therapy
- Previous or current hospital admission due to cardiac arrest
- Refractory cardiogenic shock
- Refractory Heart Failure (ACC/AHA guidelines Stage D heart Failure)
- Left ventricular ejection fraction \< 30%
- (Estimated) glomerular filtration rate \< 25 ml/min or on dialysis
- Severe hepatic insufficiency (Child-Pugh class C)
- Severe chronic obstructive pulmonary disease (confirmed by pulmonary function tests, or requiring long-term home oxygen therapy or long-term use of corticosteroids)
- History of cardiac surgery
- Pregnant or lactating women
- Combined with malignant tumors and other serious diseases, the expected life span is less than 1 year
- Neuropsychiatric disorders, unable to cooperate with management;
- Participation in other clinical trials within the past year;
- Other circumstances considered to be inappropriate for this study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.