Application of Index of Microcirculatory Resistance to Evaluate Myocardial Protection After Ischemic Adaptation
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2015
CompletedFirst Submitted
Initial submission to the registry
June 29, 2021
CompletedFirst Posted
Study publicly available on registry
July 7, 2021
CompletedJuly 9, 2021
January 1, 2014
12 months
June 29, 2021
July 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
IMR
index of microcirculatory resistance measured during coronary intervention.
detected immediately after percutaneous coronary intervention
Secondary Outcomes (1)
MACEs after PCI
6 months
Study Arms (2)
Ischemic postconditioning
EXPERIMENTALRoutine 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
No Ischemic postconditioning
ACTIVE COMPARATORRoutine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University third hospital
Beijing, Beijing Municipality, 100089, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lijun Lijun
Peking University Third Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2021
First Posted
July 7, 2021
Study Start
January 1, 2014
Primary Completion
December 31, 2014
Study Completion
June 30, 2015
Last Updated
July 9, 2021
Record last verified: 2014-01
Data Sharing
- IPD Sharing
- Will not share