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NCT Number: NCT04952740

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University third hospital

Beijing, Beijing Municipality, 100089, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IPC+PCI

Procedure

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

Other names: Ischemic postconditioning

No IPC

Procedure

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

Other names: Routine PCI

Primary outcomes

  1. IMR

    Time frame: detected immediately after percutaneous coronary intervention

    index of microcirculatory resistance measured during coronary intervention.

Secondary outcomes

  1. MACEs after PCI

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 7, 2021
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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