Mulltimodal Dynamic Risk Assessment Systems of Heart Failure in Patients With Myocardial Infarction.

NCT ID: NCT05760157

Last Updated: 2023-03-08

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

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Recruitment Status

RECRUITING

Total Enrollment

567 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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This study aims to explore the heart failure risk model based on the dynamic data of patients with different outcome nodes after myocardial infarction to correct the heart failure risk of patients timely.

Detailed Description

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Heart failure (HF) is the most common complication of acute myocardial infarction (AMI), which seriously affects the prognosis and quality of life of patients. After successful revascularization, the risk of heart failure in patients with acute myocardial infarction is closely related to the state of coronary microcirculation, and the risk of heart failure also changes dynamically with the prognosis of patients. However, current heart failure prediction models only include routine baseline variables to assess short-and long-term risk and lack newly explored new risk factors for heart failure-coronary microcirculation function, there are static, single defects. Therefore, this study is intended to be based on patients with acute ST-segment elevation myocardial infarction who had an infarct artery in the anterior descending artery and underwent emergency percutaneous coronary intervention to open the culprit lesion within 12 hours, according to the multi-dimensional data of clinical epidemiology, serology, radiology, and microcirculation resistance index based on coronary angiography during hospitalization and 6 and 12 months after discharge, respectively, to construct a multimodal dynamic predictive model for heart failure risk at 0-24 months, 6-24 months, and 12-24 months after acute myocardial infarction, to explore the heart failure risk model based on the dynamic data of different outcome nodes of patients after myocardial infarction, and to achieve the goal of timely correction of heart failure risk of patients, which is multi-linear, dynamic and practical, to provide a stage-by-stage reference for follow-up.

Conditions

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Heart Failure Acute Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Modeling cohort

The first 425(425/567,75%) patients with acute ST-segment elevation myocardial infarction were used to establish a heart failure risk prediction model.

Possible risk factors of heart failure

Intervention Type OTHER

Demographic data, previous medical history data, physical examination, ECG examination, blood routine, blood biochemistry, the peak value of myocardial injury markers, serum markers of heart failure, high-sensitivity C-reactive protein Coronary angiography, interventional treatment, microcirculation resistance index caIMR calculation based on coronary angiography Doppler echocardiography, medication during hospitalization, NYHA cardiac function grading before discharge, and 6-minute walk test before discharge.

Validation cohort

The latter 142(142/567,25%) patients with acute ST-segment elevation myocardial infarction were used to further validate the validity and predictive power of the risk model

Possible risk factors of heart failure

Intervention Type OTHER

Demographic data, previous medical history data, physical examination, ECG examination, blood routine, blood biochemistry, the peak value of myocardial injury markers, serum markers of heart failure, high-sensitivity C-reactive protein Coronary angiography, interventional treatment, microcirculation resistance index caIMR calculation based on coronary angiography Doppler echocardiography, medication during hospitalization, NYHA cardiac function grading before discharge, and 6-minute walk test before discharge.

Interventions

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Possible risk factors of heart failure

Demographic data, previous medical history data, physical examination, ECG examination, blood routine, blood biochemistry, the peak value of myocardial injury markers, serum markers of heart failure, high-sensitivity C-reactive protein Coronary angiography, interventional treatment, microcirculation resistance index caIMR calculation based on coronary angiography Doppler echocardiography, medication during hospitalization, NYHA cardiac function grading before discharge, and 6-minute walk test before discharge.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 18-75 years old (including threshold), gender unlimited
2. acute ST-segment elevation myocardial infarction was diagnosed, and the following two criteria were met: A) ischemic chest pain lasting ≥30 min;B) ECG indicating ST-segment elevation ≥0.1 mV in two or more limb leads and/or ≥0.2 mV in two or more adjacent chest leads
3. Coronary angiography confirmed that the culprit's vessel was located in the anterior descending branch, and the proximal and middle segments of the anterior descending branch were occluded (TIMI blood flow 0 or 1), Or TIMI blood flow grade 2 with obvious thrombus (TIMI thrombus score ≥ 2 points, which is determined after the guide wire passes and restores the forward blood flow. The TIMI thrombus score is determined as follows: 0 point: no thrombus is determined;1 point: blurred thrombus image is visible;2 point: clear thrombus image, but the length of the thrombus image is less than 1/2 vessel diameter;3 point: clear thrombus image, the length of the thrombus image is 1/2\~2 times the vessel diameter;4 point: clear thrombus image, the thrombus image is more than 2 times the vessel diameter;5 points : complete occlusion of blood vessels)

4:Emergency PCI revascularization was completed within 12 hours after the occurrence of myocardial infarction. Postoperative angiography confirmed that residual stenosis was less than 50%.

5: Sign the informed consent form voluntarily

Exclusion Criteria

1. Severe heart failure at discharge (NYHA III/IV, EF\<30%);Or patients with severe hemodynamic instability and cardiogenic shock, defined as systolic blood pressure\<90 mmHg, and/or cardiac index\<2.2 L/min/m2 during continuous (\>30 minutes) attacks, identified as secondary cardiac insufficiency, and/or requiring extraintestinal muscle strength or vasoconstrictor or mechanical support to maintain blood pressure and cardiac index above these specified levels.
2. patients undergoing coronary artery bypass grafting
3. Patients with mechanical complications after myocardial infarction
4. prolonged or invasive cardiopulmonary resuscitation
5. Patients with acute pericarditis, infective endocarditis, severe valvular heart disease and cardiomyopathy
6. Serious liver and kidney failure and other diseases, mental disorders or cognitive disorders
7. The expected survival of tumor patients is less than 2 years
8. patients who are participating in other interventional clinical trials
9. Those who refuse to participate or are clearly unable to complete the follow-up according to the established time point.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Navy General Hospital, Beijing

OTHER

Sponsor Role collaborator

Beijing Luhe Hospital

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Jian Liu

OTHER

Sponsor Role lead

Responsible Party

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Jian Liu

Medical Doctor, Chief physician, Professor of Medicine of PUHSC, Doctorial supervisor of PUHSC

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jian Liu

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Jian Liu

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Liu

Role: CONTACT

13801373121

Xiaofeng Su

Role: CONTACT

18811332533

Facility Contacts

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Jian Liu

Role: primary

13801373121

Xiaofeng Su

Role: backup

18811332533

References

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Other Identifiers

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RDGS2022-08

Identifier Type: -

Identifier Source: org_study_id

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