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

Sponsor
Jian Liu (Other)
Overall Status
Recruiting
CT.gov ID
NCT05760157
Collaborator
Peking University Third Hospital (Other), Beijing Anzhen Hospital (Other), Navy General Hospital, Beijing (Other), Beijing Luhe Hospital (Other), Beijing Chao Yang Hospital (Other)
567
Enrollment
1
Location
36
Anticipated Duration (Months)
15.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Possible risk factors of heart failure

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
567 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
To Establish a Multimodal Dynamic Risk Assessment System of Heart Failure in Patients With Myocardial Infarction Based on Coronary Microcirculation.
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

Other: 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.
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

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Composite endpoint of death or re-admission due to heart failure or aggravation of heart failure symptoms. [Within 24 months after discharge]

    Readmission due to heart failure was defined as admission with a primary diagnosis of heart failure presenting as a new or worsening heart failure symptom or sign accompanied by elevated natriuretic peptide levels or objective evidence of imaging suggestive of pulmonary systemic congestion; He was treated for heart failure during his hospital stay. Heart failure symptoms aggravate refers to aggravate to New York cardiac function class (NYHA) III/IV

Secondary Outcome Measures

  1. Changes in left ventricular ejection fraction [Within 24 months after discharge]

    The difference in left ventricular ejection fraction during follow-up

  2. The change of BNP/NT-pro-BNP. [Within 24 months after discharge]

    The difference in BNP/NT-pro-BNP during follow-up

  3. Changes in 6-minute walking experiment. [Within 24 months after discharge]

    Distance difference of 6-minute walking test during follow-up

  4. Changes in patients' subjective quality of life score [Within 24 months after discharge]

    The difference in quality of life scores during follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jian Liu Beijing China

Sponsors and Collaborators

  • Jian Liu
  • Peking University Third Hospital
  • Beijing Anzhen Hospital
  • Navy General Hospital, Beijing
  • Beijing Luhe Hospital
  • Beijing Chao Yang Hospital

Investigators

  • Principal Investigator: Jian Liu, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jian Liu, Medical Doctor, Chief physician, Professor of Medicine of PUHSC, Doctorial supervisor of PUHSC, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT05760157
Other Study ID Numbers:
  • RDGS2022-08
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jian Liu, Medical Doctor, Chief physician, Professor of Medicine of PUHSC, Doctorial supervisor of PUHSC, Peking University People's Hospital
acute myocardial infarction
heart failure
dysfunction of coronary microcirculation
risk assessment
Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Infarction

Study Results

No Results Posted as of Mar 8, 2023