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

NCT05760157 | Unknown

• 1 other identifier: RDGS2022-08
• Study Type: observational
• Target: 567
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Acute Myocardial Infarction

Keywords

acute myocardial infarction; heart failure; dysfunction of coronary microcirculation; risk assessment

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of death or re-admission due to heart failure or aggravation of heart failure symptoms.

  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

  Within 24 months after discharge

Secondary Outcomes (4)

• Changes in left ventricular ejection fraction

  Within 24 months after discharge

• The change of BNP/NT-pro-BNP.

  Within 24 months after discharge

• Changes in 6-minute walking experiment.

  Within 24 months after discharge

• Changes in patients' subjective quality of life score

  Within 24 months after discharge

Study Arms (2)

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

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

Interventions

Possible risk factors of heart failure 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.

Modeling cohort; Validation cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From January 2023 to December 2023, the patients with acute ST-segment elevation myocardial infarction whose anterior descending branch is the infarcted artery were selected consecutively by the People's Hospital of Peking University, the Third Hospital of Peking University, Anzhen Hospital affiliated to Capital Medical University, the Sixth Medical Center of the General Hospital of the People's Liberation Army, Beijing Luhe Hospital, and Beijing Chaoyang Hospital

You may qualify if:

• Age 18-75 years old (including threshold), gender unlimited
• 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
• 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)
• ：Emergency PCI revascularization was completed within 12 hours after the occurrence of myocardial infarction. Postoperative angiography confirmed that residual stenosis was less than 50%.
• : Sign the informed consent form voluntarily

You may not qualify if:

• 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.
• patients undergoing coronary artery bypass grafting
• Patients with mechanical complications after myocardial infarction
• prolonged or invasive cardiopulmonary resuscitation
• Patients with acute pericarditis, infective endocarditis, severe valvular heart disease and cardiomyopathy
• Serious liver and kidney failure and other diseases, mental disorders or cognitive disorders
• The expected survival of tumor patients is less than 2 years
• patients who are participating in other interventional clinical trials
• Those who refuse to participate or are clearly unable to complete the follow-up according to the established time point.

Sponsors & Collaborators

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

Study Sites (1)

Jian Liu

Beijing, China

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jian Liu

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Liu

CONTACT

13801373121; drjianliu@163.com

Xiaofeng Su

CONTACT

18811332533; sxsuxiaofeng@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Chief physician, Professor of Medicine of PUHSC, Doctorial supervisor of PUHSC

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 8, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)