Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)
- Conditions
- Unstable Angina Pectoris
- Interventions
- Other: low temperature contrast
- Registration Number
- NCT03700567
- Brief Summary
Percutaneous coronary intervention (PCI) has become one of the main treatments for rapid recovery of revascularization in patients with coronary heart disease (CHD). PCI has some advantages, such as easy operation, small trauma and rapid recovery. It can significantly improve myocardial ischemic symptom and reduce the incidence of cardiovascular adverse events in CHD patients. However, many studies have found that the incidence of PCI-related myocardial injury is relatively high, and affect the efficacy of PCI and prognosis in patients with unstable angina pectoris (UAP). A meta-analysis of a total of 7578 patients with UAP from 15 studies who underwent PCI was found to have a 28.7% increase in myocardial biomarkers after PCI. The objective of this randomized control trial is to gain a clinical insight on the use of low temperature contrast for the treatment of PCI-related myocardial injury in UAP patients. The primary objective is assess efficacy and safety of low temperature contrast for the treatment of PCI-related myocardial injury in UAP patients.
- Detailed Description
The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in levels of myocardial injury biomarkers (such as TNI and CK-MB) between low temperature contrast group and room temperature contrast group. Based on previous study, the incidence rate of PCI-related myocardial injury is 28.7% in UAP patients undergoing PCI. And in our study the expected incidence rate of PCI-related myocardial injury is up to 14.3% in UAP patients undergoing PCI after treatment with low temperature contrast. Moreover, the investigators estimated 10% loss follow-up of these patients in each arm. As a result, a total of 440 UAP patients were required, and with 220 patients per group as a ratio of 1:1 randomization.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
- De novo lesions
- Those who meet the diagnostic criteria of unstable angina pectoris
- New generation drug eluting stent implantation
- Only single coronary artery treated at this time
- Those who meet the diagnostic criteria of acute myocardial infarction
- Those who meet the diagnostic criteria of stable angina pectoris
- Patients with cardio-genic shock
- Patients with multiple organ failure
- Patients allergic to contrast
- Patients who can not tolerate dual antiplatelet therapy
- Patients who can't tolerate anticoagulation
- Recently infected patients
- Patients with hepatorenal dysfunction
- Thrombotic lesion of coronary artery
- Chronic total coronary occlusion lesion
- Patients with complex coronary bifurcation requiring two stent strategy
- Severe coronary calcified lesion
- Patients with percutaneous coronary angioplasty
- Patients with directional coronary atherectomy or rotational atherectomy
- Patients with drug coated balloon treatment
- Patients with bioabsorbable vascular scaffold implantation
- Previous percutaneous coronary intervention or coronary artery bypass graft
- Patients with active stage of autoimmune disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low temperature contrast low temperature contrast A total of 220 patients are assigned to low temperature contrast group after randomization schedule.
- Primary Outcome Measures
Name Time Method The incidence rate of PCI-related myocardial injury in UAP patients 3 days after PCI 3 days after PCI the incidence rate of PCI-related myocardial injury indicated by the changes of myocardial injury biomarkers (such as TNI and CK-MB) in UAP patients between low temperature contrast and room temperature contrast groups
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
The People's hospital of Yixing
🇨🇳Yixing, Jiangsu, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
The First People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
The First People's Hospital of Chuzhou
🇨🇳Chuzhou, Anhui, China
MingGuang People's Hospital
🇨🇳Chuzhou, Anhui, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China