Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)
NCT ID: NCT03700567
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
440 participants
INTERVENTIONAL
2018-08-01
2023-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low temperature contrast
A total of 220 patients are assigned to low temperature contrast group after randomization schedule.
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.
room temperature contrast
A total of 220 patients are assigned to room temperature contrast group after randomization schedule.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
100 Years
ALL
No
Sponsors
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Nanjing First Hospital, Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Fei Ye, MD
Role: PRINCIPAL_INVESTIGATOR
Nanjing First Hospital, Nanjing Medical University
Locations
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The First People's Hospital of Chuzhou
Chuzhou, Anhui, China
MingGuang People's Hospital
Chuzhou, Anhui, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The People's hospital of Yixing
Yixing, Jiangsu, China
Countries
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References
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Moschovitis A, Cook S, Meier B. Percutaneous coronary interventions in Europe in 2006. EuroIntervention. 2010 Jun;6(2):189-94. doi: 10.4244/EIJV7I6A31.
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.
Other Identifiers
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KY20180713-03
Identifier Type: -
Identifier Source: org_study_id
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