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Application of Index of Microcirculatory Resistance to Evaluate Myocardial Protection After Ischemic Adaptation

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IPC+PCI
No IPC
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years old, no gender limit;
  • First episode of STEMI (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation in two or more adjacent leads on the ECG or new left bundle branch block; with or without elevated myocardial markers), The onset time is within 12 hours, and emergency interventional treatment is planned;
  • Agree and cooperate to participate in this research.

Exclusion Criteria:

  • Old myocardial infarction;
  • Killip grade of cardiac function ≥ grade III or cardiogenic shock;
  • Systolic blood pressure ≤100mmHg;
  • Bradycardia, HR<60pbm, or AVB above II degree;
  • Past history of asthma or severe COPD;
  • Severe liver and kidney dysfunction.

Sites / Locations

  • Peking University third hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ischemic postconditioning

No Ischemic postconditioning

Arm Description

Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles

Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.)

Outcomes

Primary Outcome Measures

IMR
index of microcirculatory resistance measured during coronary intervention.

Secondary Outcome Measures

MACEs after PCI
MACEs includes cardiogenic death, non-fatal myocardial infarction, malignant arrhythmia, unplanned revascularization, unstable angina pectoris requiring hospitalization and severe heart failure requiring hospitalization

Full Information

First Posted
June 29, 2021
Last Updated
July 8, 2021
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04952740
Brief Title
Application of Index of Microcirculatory Resistance to Evaluate Myocardial Protection After Ischemic Adaptation
Official Title
Application of Index of Microcirculatory Resistance to Evaluate Myocardial Protection After Ischemic Adaptation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
June 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

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
To evaluate the protective effect of IPC on the myocardial microcirculation response through IMR and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients.
Detailed Description
This study is a clinical randomized controlled study, applying index of microcirculatory resistance (IMR) to evaluate the myocardial protection of ischemic postconditioning (IPC) in patients receiving direct PCI treatment for acute myocardial infarction.IMR is a quantitative evaluation index of microcirculation status. IPC has been reported to reduce ischemia-reperfusion injury and has a myocardial protective effect.The research plan divides patients into IPC and non-IPC groups at random. After the infarction-related artery is successfully implanted with a stent, the pressure guide wire is used to measure IMR and CFR in the state of maximal expansion of the microcirculation induced by intravenous ATP infusion.And analyze whether there are differences in indicators between the two groups and the relationship between these indicators and the patient's myocardial level reperfusion, cardiac function and prognosis.The purpose is to evaluate the myocardial protection of IPC and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients. It is expected that the target IPC can improve the IMR value, and IMR can predict the degree of myocardial reperfusion and cardiac function and prognosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ischemic postconditioning
Arm Type
Experimental
Arm Description
Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles
Arm Title
No Ischemic postconditioning
Arm Type
Active Comparator
Arm Description
Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.)
Intervention Type
Procedure
Intervention Name(s)
IPC+PCI
Other Intervention Name(s)
Ischemic postconditioning
Intervention Description
Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles
Intervention Type
Procedure
Intervention Name(s)
No IPC
Other Intervention Name(s)
Routine PCI
Intervention Description
Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.
Primary Outcome Measure Information:
Title
IMR
Description
index of microcirculatory resistance measured during coronary intervention.
Time Frame
detected immediately after percutaneous coronary intervention
Secondary Outcome Measure Information:
Title
MACEs after PCI
Description
MACEs includes cardiogenic death, non-fatal myocardial infarction, malignant arrhythmia, unplanned revascularization, unstable angina pectoris requiring hospitalization and severe heart failure requiring hospitalization
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old, no gender limit; First episode of STEMI (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation in two or more adjacent leads on the ECG or new left bundle branch block; with or without elevated myocardial markers), The onset time is within 12 hours, and emergency interventional treatment is planned; Agree and cooperate to participate in this research. Exclusion Criteria: Old myocardial infarction; Killip grade of cardiac function ≥ grade III or cardiogenic shock; Systolic blood pressure ≤100mmHg; Bradycardia, HR<60pbm, or AVB above II degree; Past history of asthma or severe COPD; Severe liver and kidney dysfunction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijun Lijun
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University third hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100089
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Application of Index of Microcirculatory Resistance to Evaluate Myocardial Protection After Ischemic Adaptation

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