Clinical trial NCT05760157: Mulltimodal Dynamic Risk Assessment Systems of Heart Failure in Patients With Myocardial Infarction.
Official title: To Establish a Multimodal Dynamic Risk Assessment System of Heart Failure in Patients With Myocardial Infarction Based on Coronary Microcirculation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Acute Myocardial Infarction
Keywords: acute myocardial infarction
heart failure
dysfunction of coronary microcirculation
risk assessment
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Beijing Anzhen Hospital
name: Navy General Hospital, Beijing
name: Beijing Luhe Hospital
name: Beijing Chao Yang Hospital
First posted: 2023-03-08
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite endpoint of death or re-admission due to heart failure or aggravation of heart failure symptoms.
timeFrame: Within 24 months after discharge
Secondary outcomes:
measure: Changes in left ventricular ejection fraction
timeFrame: Within 24 months after discharge
measure: The change of BNP/NT-pro-BNP.
timeFrame: Within 24 months after discharge
measure: Changes in 6-minute walking experiment.
timeFrame: Within 24 months after discharge
measure: Changes in patients' subjective quality of life score
timeFrame: Within 24 months after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jian Liu
Study officials:
affiliation: Peking University People's Hospital
name: Jian Liu
role: PRINCIPAL_INVESTIGATOR
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