Clinical trial NCT03700567: Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)
Official title: Safety and Efficacy of Low Temperature Contrast for the Treatment of PCI-related Myocardial Injury in Patients With Unstable Angina Pectoris (LOTA-I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unstable Angina Pectoris
Keywords: low temperature
contrast
PCI-related myocardial injury
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence rate of PCI-related myocardial injury in UAP patients 3 days after PCI
timeFrame: 3 days after PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Chuzhou
country: China
facility: The First People's Hospital of Chuzhou
state: Anhui
city: Chuzhou
country: China
facility: MingGuang People's Hospital
state: Anhui
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yixing
country: China
facility: The People's hospital of Yixing
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Fei Ye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moschovitis A, Cook S, Meier B. Percutaneous coronary interventions in Europe in 2006. EuroIntervention. 2010 Jun;6(2):189-94. doi: 10.4244/EIJV7I6A31.
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.