Unstable Angina Pectoris Clinical Trial
— LOTA-IOfficial title:
Safety and Efficacy of Low Temperature Contrast for the Treatment of PCI-related Myocardial Injury in Patients With Unstable Angina Pectoris (LOTA-I)
Verified date | November 2023 |
Source | Nanjing First Hospital, Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 440 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | The First People's Hospital of Changzhou | Changzhou | Jiangsu |
China | MingGuang People's Hospital | Chuzhou | Anhui |
China | The First People's Hospital of Chuzhou | Chuzhou | Anhui |
China | The First People's Hospital of Lianyungang | Lianyungang | Jiangsu |
China | Nanjing First Hospital | Nanjing | Jiangsu |
China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu |
China | The People's hospital of Yixing | Yixing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University |
China,
Moschovitis A, Cook S, Meier B. Percutaneous coronary interventions in Europe in 2006. EuroIntervention. 2010 Jun;6(2):189-94. — View Citation
Testa L, Van Gaal WJ, Biondi Zoccai GG, Agostoni P, Latini RA, Bedogni F, Porto I, Banning AP. Myocardial infarction after percutaneous coronary intervention: a meta-analysis of troponin elevation applying the new universal definition. QJM. 2009 Jun;102(6):369-78. doi: 10.1093/qjmed/hcp005. Epub 2009 Mar 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence rate of PCI-related myocardial injury in UAP patients 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 | 3 days after PCI |
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