Clinical trial NCT04952740: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: IMR
timeFrame: detected immediately after percutaneous coronary intervention
Secondary outcomes:
measure: MACEs after PCI
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Lijun Lijun
role: PRINCIPAL_INVESTIGATOR
References: