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

NCT ID: NCT04952740

Last Updated: 2021-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ischemic postconditioning

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

Group Type EXPERIMENTAL

IPC+PCI

Intervention Type 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

No Ischemic postconditioning

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

Group Type ACTIVE_COMPARATOR

No IPC

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IPC+PCI

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

No IPC

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ischemic postconditioning Routine PCI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lijun Lijun

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University third hospital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013127

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.