ST-segment Elevation Myocardial Infarction (STEMI)
Conditions
Keywords
Thrombus Aspiration, Coronary Intervention, Thrombus Burden, ST-segment Elevation Myocardial Infarction
Brief summary
This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.
Detailed description
This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.
Interventions
PROCEDUREThrombus aspiration
Percutaneous Coronary Intervention with manual aspiration thrombectomy
PROCEDUREPCI Alone
Percutaneous Coronary Intervention without manual aspiration thrombectomy
Sponsors
Zhongshan People's Hospital, Guangdong, China
Kaiping Central Hospital
Second Affiliated Hospital of Shantou University Medical College
The Third Xiangya Hospital of Central South University
Sihui City People's Hospital
Shenzhen Baoan District Shiyan People's Hospital
People's Hospital of Nanxiong County
Yuebei People's Hospital
Weifang Medical University
Wuzhou Gongren Hospital
Dafeng Hospital of Chaoyang District in Shantou City
Shenzhen Baoan People's Hospital
Dongguan People's Hospital
Yangchun People's Hospital
Taishan People's Hospital
The Second People's Hospital of Foshan
Guangzhou Hospital of integrated Traditional and West Medicine
Guangning People's Hospital
Foshan Sanshui District People's Hospital
Qingyuan People's Hospital
Luhe County People's Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
The Fourth People's Hospital of Chenzhou
People's Hospital of Dapu County
Shenzhen People's Hospital
Heyuan people's Hospital
Huaiji People's Hospital
People's Hospital of Yingde City
Qingyuan Hospital of Traditional Chinese Medicine Affiliated To Guangzhou University of Traditional Chinese Medicine
Zhongshan Hospital Of Traditional Chinese Medicine
The Third Affiliated Hospital of Guangzhou Medical University
Lianzhou People's Hospital
Lianping Xian Ren Ming Yi Yuan
Guangxi Zhuang Autonomous Region Nationalities Hospital
Liuzhou Municipal Liutie Central Hospital
Chen Zhou 3RD People's Hospital
Longgang District People's Hospital of Shenzhen
The Affiliated Shunde Hospital of Jinan University
Shenzhen Longhua District Central Hospital
Shantou Central Hospital
Tongxiang First People's Hospital
Bobai County People's Hospital, Guangxi
Meizhou Traditional Chinese Medicine Hospital
The Third Affiliated Hospital of Sun Yat-Sen University, Yuedong Hospital
Shenzhen Third People's Hospital
Yangjiang People's Hospital
Jiangmen Central Hospital
Eighth Affiliated Hospital, Sun Yat-sen University
The First People's Hospital of Kashgar Erea
First People's Hospital of Foshan
Zhaoqing Gaoyao People's Hospital
People's Hospital of Nanhai District, Foshan
The Second Affiliated Hospital of Dalian Medical University
Nanning Second People's Hospital
The Second People's Hospital of Nanhai District of Foshan
Shangyou People's Hospital
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years; 2. STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms; 3. High thrombus burden after guidewire passes the lesion (TIMI thrombus grade ≥3); 4. Informed consent must be voluntary;
Exclusion criteria
1. Haemodynamic instability or cardiogenic shock; 2. After thrombolytic therapy; 3. The predicted survival time is less than 6 months due to non-cardiac disease; 4. History of coronary artery bypass grafting; 5. Participate in other researches within 30 days; 6. Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet therapy; 7. Patients were considered unsuitable by other researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events | up to180 days | The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | up to 30 days | The symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular |
| Composite adverse cardiocerebrovascular events | up to 1 year | The first occurence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization or stroke. |
Countries
China
Contacts
Primary ContactPengchen He, MD
Outcome results
None listed