Evaluation of MTH in PCI Under VA-ECMO for AMICS

NCT07186972 | Not Yet Recruiting

• 1 other identifier: 2025AZB6019
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Myocardial Infarction Complicated With Cardiogenic Shock; Mild Therapeutic Hypothermia; Venous-arterial Extracorporeal Membrane Oxygenation

Outcome Measures

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.

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

Secondary Outcomes (14)

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

  72 hours post-percutaneous coronary intervention

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

  72 hours post-percutaneous coronary intervention

• Cardiac function

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

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

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

• Arterial blood lactate levels

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

Study Arms (2)

Control

NO INTERVENTION

Maintaining a target temperature of 36.5℃ (±0.3℃) during percutaneous coronary intervention

Mild therapeutic hypothermia

EXPERIMENTAL

Cooling down to a target temperature of 33.0°C-34.0°C before percutaneous coronary intervention, and then rewarming was initiated after 24 hours with a speed of 0.25°C/h to a target temperature of 36.5°C (± 0.3°C).

Procedure: Mild therapeutic hypothermia

Interventions

Mild therapeutic hypothermia PROCEDURE

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.

Mild therapeutic hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Known end-stage renal disease (e.g., on dialysis or post-kidney transplantation) or severe liver failure (e.g., cirrhosis or acute hepatitis).
• Contraindications to hypothermia therapy, such as cryoglobulinemia, sickle cell disease, cold agglutinin disease, and vasospastic disorders (e.g., Raynaud's disease and thromboangiitis obliterans).
• Refusal to undergo 99mTc-sestamibi single photon emission tomography imaging or presence of known or suspected contraindications to 99mTc-sestamibi single photon emission tomography imaging.
• Pregnency.
• Currently participation in other interventional clinical trials.
• Refusal to sign informed consent related to this trial.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09