Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)
LOTA-I
1 other identifier
interventional
440
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 29, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedNovember 18, 2023
November 1, 2023
4.9 years
September 29, 2018
November 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
low temperature contrast
EXPERIMENTALA total of 220 patients are assigned to low temperature contrast group after randomization schedule.
room temperature contrast
NO INTERVENTIONA total of 220 patients are assigned to room temperature contrast group after randomization schedule.
Interventions
UAP patients undergoing PCI were performed with low temperature contrast. The investigators used thermal insulation equipment to keep contrast at 5℃. The EKG and blood pressure were monitored during the PCI procedure. After PCI, the investigators monitored levels of myocardial injury biomarkers for 3 days every 8 hours.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
The First People's Hospital of Chuzhou
Chuzhou, Anhui, 239000, China
MingGuang People's Hospital
Chuzhou, Anhui, 239400, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222061, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
The People's hospital of Yixing
Yixing, Jiangsu, 214200, China
Related Publications (2)
Moschovitis A, Cook S, Meier B. Percutaneous coronary interventions in Europe in 2006. EuroIntervention. 2010 Jun;6(2):189-94. doi: 10.4244/EIJV7I6A31.
PMID: 20562067BACKGROUNDTesta 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.
PMID: 19286891BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fei Ye, MD
Nanjing First Hospital, Nanjing Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2018
First Posted
October 9, 2018
Study Start
August 1, 2018
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share