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NCT03700567: LOTA-I

Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)

Completed NA Last updated 18 November 2023
What this trial tests

NA trial testing low temperature contrast in Unstable Angina Pectoris in 440 participants. Completed in 1 July 2023.

Timeline
1 August 2018
Primary endpoint
1 July 2023
1 July 2023

Quick facts

Lead sponsorNanjing First Hospital, Nanjing Medical University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment440
Start date1 August 2018
Primary completion1 July 2023
Estimated completion1 July 2023
Sites7 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Nanjing First Hospital, Nanjing Medical University

Who can join

Adults 18 to 100, any sex, with Unstable Angina Pectoris. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Unstable Angina Pectoris

Currently open trials in the same condition.

Other Nanjing First Hospital, Nanjing Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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