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

Heart Failure Clinical Trial

Official title:

To Establish a Multimodal Dynamic Risk Assessment System of Heart Failure in Patients With Myocardial Infarction Based on Coronary Microcirculation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760157
• Other study ID #: RDGS2022-08
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: Peking University People's Hospital
• Contact: Jian Liu
• Phone: 13801373121
• Email: drjianliu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 567
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
China	Jian Liu	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Jian Liu	Beijing Anzhen Hospital, Beijing Chao Yang Hospital, Beijing Luhe Hospital, Navy General Hospital, Beijing, Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in left ventricular ejection fraction	The difference in left ventricular ejection fraction during follow-up	Within 24 months after discharge
Secondary	The change of BNP/NT-pro-BNP.	The difference in BNP/NT-pro-BNP during follow-up	Within 24 months after discharge
Secondary	Changes in 6-minute walking experiment.	Distance difference of 6-minute walking test during follow-up	Within 24 months after discharge
Secondary	Changes in patients' subjective quality of life score	The difference in quality of life scores during follow-up	Within 24 months after discharge