Evaluation of MTH in PCI Under VA-ECMO for AMICS

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

This study is a randomized controlled trial conducted at Beijing Anzhen Hospital, Capital Medical University. The primary objective is to assess the efficacy of mild therapeutic hypothermia in reducing infarct size and improving cardiac function in patients receiving percutaneous coronary intervention under venous-arterial extracorporeal membrane oxygenation for acute myocardial infarction complicated with cardiogenic shock. Secondary objectives include evaluating the safety of mild therapeutic hypothermia and its impact on venous-arterial extracorporeal membrane oxygenation weaning success and short-term survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with acute myocardial infarction complicated by cardiogenic shock who undergo emergency percutaneous coronary intervention under venoarterial extracorporeal membrane oxygenation support and endotracheal intubation.

Patients diagnosed with anterior wall myocardial infarction.

Aged ≥18 years.

Disqualifiers

Cardiogenic shock lasting more than 12 hours or a history of chronic congestive heart failure.

History of prior coronary artery intervention, coronary artery bypass grafting, heart transplantation, heart-lung transplantation, or left ventricular assist device implantation.

Cardiogenic shock associated with mechanical complications of acute myocardial infarction, such as ventricular septal rupture, acute mitral regurgitation, acute ventricular septal defect, and cardiac tamponade.

Refractory out-of-hospital cardiac arrest or cardiopulmonary resuscitation lasting longer than 45 minutes.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mild therapeutic hypothermia

    Procedure/Surgery

    Before percutaneous coronary intervention, cooling was maintained with venous-arterial extracorporeal membrane oxygenation in patients receiving mild therapeutic hypothermia. By protocol, cooling down to the target temperature of 33°C-34°C was set at the maximum possible cooling rate. After the target temperature was reached, it was maintained for 24 hours with the temperature regulation function of the extracorporeal membrane oxygenation system by central temperature measurement in the urinary bladder. After 24 hours, rewarming was initiated with a speed of 0.25°C/h to a target temperature of 36.5℃ (± 0.3℃). To avoid shivering in the mild therapeutic hypothermia group, the patients were treated with a protocol including deep sedation and optional muscle relaxation.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Mild therapeutic hypothermiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Myocardial Salvage Index (MSI)

Myocardial Salvage Index (MSI) is measured by 99mTc-sestamibi single photon emission tomography at day 3 (± 1 day) post-percutaneous coronary intervention, calculated as MSI = (area at risk-final infarct size)/area at risk, where area at risk is the area at risk and final infarct size is the final infarct size.

Time frame
3 day (± 1 day) post-percutaneous coronary intervention

Secondary outcomes

1

Area under the curve of serum creatine kinase-MB within 72 hours post-percutaneous coronary intervention

Time frame
72 hours post-percutaneous coronary intervention
2

Area under the curve of serum cardiac troponin I within 72 hours post-percutaneous coronary intervention

Time frame
72 hours post-percutaneous coronary intervention
3

Cardiac function

Echocardiographic indicators, including left ventricular ejection fraction, cardiac index, left ventricular end-systolic volume index, left ventricular end-diastolic volume index, the ratio of early diastolic filling velocity to atrial systolic filling velocity, maximum rate of left ventricular pressure rise/decline, measured every 24 hours post-percutaneous coronary intervention

Time frame
Baseline, and every 24 hours post-percutaneous coronary intervention up to discharge.
4

Serum N-terminal pro-B-type natriuretic peptide levels

Serum N-terminal pro-B-type natriuretic peptide measured every 4 hours post-percutaneous coronary intervention

Time frame
Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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