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

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.

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Key information

Conditions

Unstable Angina Pectoris Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MingGuang People's Hospital, Chuzhou, Anhui, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low temperature contrast

Other

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Safety and Efficacy of Low Temperature Contrast for the Treatment of PCI-related Myocardial Injury in Patients With Unstable Angina Pectoris (LOTA-I)

Acronym: LOTA-I

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Oct 9, 2018
Registry last updated: Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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