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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 11, 2019
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Unstable Angina Pectoris Other: low temperature contrast Not Applicable

Detailed Description:
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. As a result, a total of 300 UAP patients were required, and with 150 patients per group as a ratio of 1:1 randomization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of unstable angina pectoris
  • Elective stent implantation

Exclusion Criteria:

  • Clinical diagnosis of acute myocardial infarction
  • Preoperative infection
  • Sustained organ failure
  • Active period of autoimmune disease
  • Percutaneous transluminal coronary angioplasty (PTCA)
  • Coronary rotary resection
  • Coronary rotational atherectomy

Information from the National Library of Medicine

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


Contacts
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Contact: Fei Ye, MD +86 13327823900 doctor_ye@126.com
Contact: Xiangqi Wu, MD +86 15250997876 15250997876@163.com

Locations
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China, Anhui
The Affiliated Hospital of Bengbu Medical College Recruiting
Bengbu, Anhui, China, 233004
Contact: Heng Zhang, MD    +8613965270077    13965270077@139.com   
Contact: Yao Chen, MD    +8613855286301    chenyao_841206@126.com   
The First People's Hospital of Chuzhou Recruiting
Chuzhou, Anhui, China, 239000
Contact: Limin Zhou, MD    +8613705503905    zhlm0902@sina.com   
Contact: Tongtong Shen, MD    +8613955016856    37024942@qq.com   
China, Jiangsu
The First People's Hospital of Changzhou Recruiting
Changzhou, Jiangsu, China, 213000
Contact: Haiyan Ke, MD    +8613511670112    khyrain2014@163.com   
Contact: Jin Zhu, MD    +8613813598210    zhujin8011@163.com   
The Second People's Hospital of Huaian Recruiting
Huaian, Jiangsu, China, 223002
Contact: Yuansheng Zhu, MD    +8613953397479    hazys0517@163.com   
Contact: Shu Guan, MD    +8615189609559    guanshu6408@163.com   
The First People's Hospital of Lianyungang Recruiting
Lianyungang, Jiangsu, China, 222061
Contact: Delu Yin, MD    +8618961326475    druseyin@163.com   
Contact: Qunxing Li, MD    +8618961321567    759045538@qq.com   
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Fei Ye, MD    +86 13327823900    doctor_ye@126.com   
Contact: Xiangqi Wu, MD    +86 15250997876    15250997876@163.com   
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China, 221006
Contact: Defeng Pan, MD    +8613852438611    1320120945@qq.com   
Contact: Jie Liu, MD    +8615252148972    515967514@qq.com   
The People's hospital of Yixing Recruiting
Yixing, Jiangsu, China, 214200
Contact: Song Yang, MD    +8618601569266    staff052@yxph.com   
Contact: Liang Xu, MD    +8618861576565    staff1015@yxph.com   
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Principal Investigator: Fei Ye, MD Nanjing First Hospital, Nanjing Medical University

Publications:
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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03700567     History of Changes
Other Study ID Numbers: KY20180713-03
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanjing First Hospital, Nanjing Medical University:
low temperature
contrast
PCI-related myocardial injury
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms