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

Primary Purpose

Unstable Angina Pectoris

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
low temperature contrast
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unstable Angina Pectoris focused on measuring low temperature, contrast, PCI-related myocardial injury

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • The First People's Hospital of ChuzhouRecruiting
  • MingGuang People's HospitalRecruiting
  • The First People's Hospital of ChangzhouRecruiting
  • The Second People's Hospital of HuaianRecruiting
  • The First People's Hospital of LianyungangRecruiting
  • Nanjing First HospitalRecruiting
  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
  • The People's hospital of YixingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

low temperature contrast

room temperature contrast

Arm Description

A total of 150 patients are assigned to low temperature contrast group after randomization schedule.

A total of 150 patients are assigned to room temperature contrast group after randomization schedule.

Outcomes

Primary Outcome Measures

The incidence rate of PCI-related myocardial injury in UAP patients 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

Secondary Outcome Measures

Full Information

First Posted
September 29, 2018
Last Updated
April 19, 2022
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03700567
Brief Title
Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI
Acronym
LOTA-I
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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. Moreover, the investigators estimated 10% loss follow-up of these patients in each arm. As a result, a total of 330 UAP patients were required, and with 165 patients per group as a ratio of 1:1 randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unstable Angina Pectoris
Keywords
low temperature, contrast, PCI-related myocardial injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low temperature contrast
Arm Type
Experimental
Arm Description
A total of 150 patients are assigned to low temperature contrast group after randomization schedule.
Arm Title
room temperature contrast
Arm Type
No Intervention
Arm Description
A total of 150 patients are assigned to room temperature contrast group after randomization schedule.
Intervention Type
Other
Intervention Name(s)
low temperature contrast
Intervention Description
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 Outcome Measure Information:
Title
The incidence rate of PCI-related myocardial injury in UAP patients 3 days after PCI
Description
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
Time Frame
3 days after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Ye, MD
Phone
+86 13327823900
Email
doctor_ye@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangqi Wu, MD
Phone
+86 15250997876
Email
15250997876@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Ye, MD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heng Zhang, MD
Phone
+8613965270077
Email
13965270077@139.com
First Name & Middle Initial & Last Name & Degree
Yao Chen, MD
Phone
+8613855286301
Email
chenyao_841206@126.com
Facility Name
The First People's Hospital of Chuzhou
City
Chuzhou
State/Province
Anhui
ZIP/Postal Code
239000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limin Zhou, MD
Phone
+8613705503905
Email
zhlm0902@sina.com
First Name & Middle Initial & Last Name & Degree
Tongtong Shen, MD
Phone
+8613955016856
Email
37024942@qq.com
Facility Name
MingGuang People's Hospital
City
Chuzhou
State/Province
Anhui
ZIP/Postal Code
239400
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianglian Ma
Phone
+8613515505166
Email
mxl0102@qq.com
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Ke, MD
Phone
+8613511670112
Email
khyrain2014@163.com
First Name & Middle Initial & Last Name & Degree
Jin Zhu, MD
Phone
+8613813598210
Email
zhujin8011@163.com
Facility Name
The Second People's Hospital of Huaian
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuansheng Zhu, MD
Phone
+8613953397479
Email
hazys0517@163.com
First Name & Middle Initial & Last Name & Degree
Shu Guan, MD
Phone
+8615189609559
Email
guanshu6408@163.com
Facility Name
The First People's Hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delu Yin, MD
Phone
+8618961326475
Email
druseyin@163.com
First Name & Middle Initial & Last Name & Degree
Qunxing Li, MD
Phone
+8618961321567
Email
759045538@qq.com
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Ye, MD
Phone
+86 13327823900
Email
doctor_ye@126.com
First Name & Middle Initial & Last Name & Degree
Xiangqi Wu, MD
Phone
+86 15250997876
Email
15250997876@163.com
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Defeng Pan, MD
Phone
+8613852438611
Email
1320120945@qq.com
First Name & Middle Initial & Last Name & Degree
Jie Liu, MD
Phone
+8615252148972
Email
515967514@qq.com
Facility Name
The People's hospital of Yixing
City
Yixing
State/Province
Jiangsu
ZIP/Postal Code
214200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Yang, MD
Phone
+8618601569266
Email
staff052@yxph.com
First Name & Middle Initial & Last Name & Degree
Liang Xu, MD
Phone
+8618861576565
Email
staff1015@yxph.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20562067
Citation
Moschovitis A, Cook S, Meier B. Percutaneous coronary interventions in Europe in 2006. EuroIntervention. 2010 Jun;6(2):189-94.
Results Reference
background
PubMed Identifier
19286891
Citation
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.
Results Reference
background

Learn more about this trial

Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI

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