Thrombus aspiration for heart attack patients with high thrombus burden
Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden
This study tests if using a special technique to remove blood clots can help heart attack patients with a lot of clots feel better and avoid serious problems after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3838 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Locations | 50 sites (Fuzhou, Fujian and 49 other locations) |
| Trial ID | NCT04212494 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of thrombus aspiration in patients experiencing ST-segment Elevation Myocardial Infarction (STEMI) with a high thrombus burden during primary percutaneous coronary intervention (PCI). It is a multicenter, open-label, randomized controlled trial where participants are assigned to receive either thrombus aspiration or standard PCI treatment. The goal is to determine if thrombus aspiration can reduce the risk of serious cardiovascular events within 180 days and stroke within 30 days after treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are experiencing STEMI and can undergo primary PCI within 12 hours of symptom onset.
Not a fit: Patients who are hemodynamically unstable, have undergone thrombolytic therapy, or have a predicted survival time of less than 6 months due to non-cardiac disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of severe complications for STEMI patients with high thrombus burden.
How similar studies have performed: Previous studies have shown varying results with thrombus aspiration in similar patient populations, indicating that while the approach has been tested, its efficacy in this specific context remains to be fully established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fuzhou, Fujian and 49 other locations
- Fujian Provincial Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
- First People's Hospital of Foshan — Foshan, Guangdong, China (Not_yet_recruiting)
- The Second People's Hospital of Nanhai District — Foshan, Guangdong, China (Recruiting)
- First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University) — Foshan, Guangdong, China (Not_yet_recruiting)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Guangzhou Panyu Central Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Guangzhou General Hospital of Guangzhou Military Command — Guangzhou, Guangdong, China (Not_yet_recruiting)
- The first Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Guangdong Provincial Hospital of traditional Chinese Medicine — Guangzhou, Guangdong, China (Not_yet_recruiting)
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- The Second Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Nanfang Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Huangpu Division of The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Huadu District People's Hospital of Guangzhou — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Huizhou Third People's Hospital — Huizhou, Guangdong, China (Not_yet_recruiting)
- Jiangmen Central Hospital — Jiangmen, Guangdong, China (Not_yet_recruiting)
- Kaiping Central Hospital — Kaiping, Guangdong, China (Recruiting)
- Maoming People's Hospital — Maoming, Guangdong, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Shantou university Medical College — Shantou, Guangdong, China (Recruiting)
- Yue Bei People's Hospital — Shaoguan, Guangdong, China (Not_yet_recruiting)
- Shenzhen People's Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
- The Eighth Affiliated Hospital, Sun Yat-Sen University — Shenzhen, Guangdong, China (Not_yet_recruiting)
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
- Shenzhen Bao'an District People's Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
- Taishan people's Hospital — Taishan, Guangdong, China (Not_yet_recruiting)
- Nanxiong people's Hospital — Xiongzhou, Guangdong, China (Not_yet_recruiting)
- People's Hospital of Yangjiang City — Yangjiang, Guangdong, China (Recruiting)
- The Second Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (Not_yet_recruiting)
- Sihui people's Hospital — Zhaoqing, Guangdong, China (Recruiting)
- Zhongshan People's Hospital — Zhongshan, Guangdong, China (Not_yet_recruiting)
- The Fifth Affiliated Hospital, Sun Yat-Sen University — Zhuhai, Guangdong, China (Not_yet_recruiting)
- Zhuhai people's Hospital — Zhuhai, Guangdong, China (Not_yet_recruiting)
- Guilin people's Hospital — Guilin, Guangxi, China (Not_yet_recruiting)
- The Second Clinical College of Hainan Medical University — Haikou, Hainan, China (Not_yet_recruiting)
- Hainan People's Hospital — Haikou, Hainan, China (Not_yet_recruiting)
- Wuhan Asia Heart Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
- The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
- GanZhou Municopal Hospital — Ganzhou, Jiangxi, China (Not_yet_recruiting)
- Shangyou Hospital — Ganzhou, Jiangxi, China (Not_yet_recruiting)
- Affiliated Hospital, Weifang Medical University — Weifang, Shandong, China (Not_yet_recruiting)
- The first Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Not_yet_recruiting)
- West China Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
- Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
- Kashgar first people's Hospital — Kashgar, Xinjiang, China (Not_yet_recruiting)
- The First Affilicated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Not_yet_recruiting)
- Yan'an Hospital of Kunming City — Kunming, Yunnan, China (Not_yet_recruiting)
- Shaoxing people's Hospital — Shaoxing, Zhejiang, China (Not_yet_recruiting)
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Pengchen He, MD
- Email: drhepengcheng@aliyun.co
- Phone: 86-13829730152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.