Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)
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|ClinicalTrials.gov Identifier: NCT03700567|
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Unstable Angina Pectoris||Other: low temperature contrast||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: low temperature contrast
A total of 150 patients are assigned to low temperature contrast group after randomization schedule.
Other: low temperature contrast
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.
No Intervention: room temperature contrast
A total of 150 patients are assigned to room temperature contrast group after randomization schedule.
- The incidence rate of PCI-related myocardial injury in UAP patients 3 days after PCI [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700567
|Contact: Fei Ye, MD||+86 firstname.lastname@example.org|
|Contact: Xiangqi Wu, MD||+86 email@example.com|
|Nanjing First Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210006|
|Contact: Fei Ye, MD +86 13327823900 firstname.lastname@example.org|
|Contact: Xiangqi Wu, MD +86 15250997876 email@example.com|
|Principal Investigator:||Fei Ye, MD||Nanjing First Hospital, Nanjing Medical University|