Using Dexmedetomidine to Protect the Heart in Patients with Severe Heart Attacks

Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction: a Double-Blind, Multicenter, Randomized, Placebo-Controlled Clinical Trial

This study is testing if giving dexmedetomidine during heart procedures can help reduce heart damage in patients having severe heart attacks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Harbin Medical University (Academic / other)
• Locations: 9 sites (Hefei, Anhui and 8 other locations)
• Trial ID: NCT04912518 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the cardioprotective effects of dexmedetomidine in patients experiencing anterior ST-segment elevation myocardial infarction (STEMI) who are undergoing primary percutaneous coronary intervention (pPCI). It is a double-blind, multicenter, randomized, placebo-controlled trial where eligible patients are assigned to receive either dexmedetomidine or a saline placebo during their procedure. The primary endpoint is to measure the myocardial infarct size using cardiac magnetic resonance imaging (CMR) five days after the event. The study aims to determine if dexmedetomidine can significantly reduce heart damage compared to placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have been diagnosed with anterior STEMI within 6 hours of symptom onset.

Not a fit: Patients with severe complications such as cardiogenic shock or significant heart rhythm issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to reduced heart damage and improved outcomes for patients suffering from severe heart attacks.

How similar studies have performed: While the specific use of dexmedetomidine in this context may be novel, previous studies have shown promising results for cardioprotective strategies in similar patient populations.

Eligibility criteria

Inclusion Criteria: the enrolled subjects must meet all of the following criteria:

* Aged 18-75 years old (inclusive);
* Diagnosed with anterior STEMI within 6h of symptom onset: (1) ischemic chest discomfort; (2) electrocardiogram (ECG) with ST elevation ≥0.2 mV in 2 or more contiguous precordial leads (one of which should be V2, V3, or V4);
* Sign the informed consent form.

Exclusion Criteria: subjects who meet any one of the following criteria are excluded from the study:

* Ventricular fibrillation, cardiogenic shock, Killip III-IV grade;
* Sinus bradycardia (heart rate sustained \<60 beats/min), PR interval\> 240ms or II-III degree atrioventricular block;
* Continuous systolic blood pressure \<120mmHg;
* Severe breathing difficulties, aterial blood oxygen saturation \<92%;
* Thrombolytic therapy has been performed before the first medical contact in the hospital;
* Consciousness disorder or past cerebrovascular disease;
* Previous history of myocardial infarction or PCI/CABG treatment;
* Known severe liver and kidney dysfunction;
* Known allergy to dexmedetomidine;
* CMR contraindications: such as claustrophobia, pacemaker or ICD implantation;
* Pregnant or lactating women;
* Malignant tumor or expected survival time \<1 year;
* Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, poor compliance, inability of the patient to comply with study procedures and/or follow up);
* Participate in other randomized controlled studies at the same time.

Where this trial is running

Hefei, Anhui and 8 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• The First Affiliated Hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• Mudanjiang Cardiovascular Hospital — Mudanjiang, Heilongjiang, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Wuhan Asia Heart Hospital — Wuhan, Hubei, China (Recruiting)
• Shaanxi Provincial People's Hospital — Xi'an, Shaanxi, China (Recruiting)
• Shanxi Cardiovascular Hospital — Taiyuan, Shanxi, China (Recruiting)
• Tianjin First Central Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Bo Yu, M.D., FACC — The Second Affiliated Hospital of Harbin Medical University
• Study coordinator: Jiannan Dai, M.D., Ph.D

Conditions ST-segment Elevation Myocardial Infarction; Percutaneous Coronary Intervention; Cardioprotection; Percutaneous coronary intervention; Dexmedetomidine