Clinical trial NCT05164601: Prognosis of Treated Acute Coronary Syndrome Patients: a Multicenter Study
Official title: A Multicenter, Prospective Cohort Study Evaluating the Prognosis of Patients with Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
Acute Myocardial Infarction
coronary heart disease
prognosis
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
Collaborators: name: Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University
name: The Third Affiliated Hospital of Jinzhou Medical University
First posted: 2021-12-20
Enrollment: 22500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute Coronary Syndrome

Brief summary: The MPCS-ACS Study (Multicenter Prospective Cohort Study on Acute Coronary Syndrome) is a comprehensive, forward-looking research project designed to evaluate the prognostic outcomes of patients diagnosed with acute coronary syndrome (ACS) who declined coronary artery bypass grafting (CABG) and underwent percutaneous coronary intervention (PCI) instead. Leveraging a multicenter approach, the study aims to collect data from a diverse patient population, thereby enhancing the generalizability and clinical relevance of its findings.

Upon enrollment, detailed information is gathered, including demographic data, clinical history, and key biochemical markers. The study also documents the various medication regimens prescribed during hospitalization to assess their influence on patient outcomes. A key feature of MPCS-ACS is its rigorous follow-up protocol, which involves regularly monitoring patients after discharge to track recovery progress and the occurrence of any subsequent cardiovascular events.

This methodical approach is designed to generate valuable insights into the long-term prognosis of ACS patients treated with PCI, ultimately contributing to the refinement of therapeutic strategies and improving the standard of care across all participating centers.

Detailed description: The Multicenter Acute Coronary Syndrome Prognosis Cohort Study (MPCS-ACS) is a comprehensive, longitudinal research initiative designed to evaluate the prognostic outcomes of patients diagnosed with acute coronary syndrome (ACS) across diverse healthcare settings. Conducted in collaboration with multiple hospitals, this study aims to collect and analyze data from ACS patients admitted between June 1, 2016, and May 31, 2021.

The study will gather an extensive range of variables, including therapeutic interventions, biochemical markers relevant to ACS management, as well as key demographic and clinical history data. By analyzing these factors, the study seeks to gain a deeper understanding of ACS treatment practices during the study period and assess their clinical efficacy.

A robust follow-up protocol is a cornerstone of MPCS-ACS, featuring routine evaluations conducted every six to twelve months after patient discharge. Follow-ups will incorporate both in-person visits and telecommunication to accommodate participants unable to return to the hospital. This dual approach is designed to maximize participant retention and ensure high-quality data collection, thereby enhancing the study's validity and impact.

Through its rigorous methodology and collaborative framework, the MPCS-ACS aims to identify key prognostic factors and outcomes for ACS patients. The ultimate goal is to inform the optimization of care strategies and elevate the standards of cardiovascular treatment across diverse healthcare systems.

Eligibility criteria: Inclusion Criteria

1. Men and women aged between 18 and 79 years.
2. Patients diagnosed with Acute Coronary Syndrome (ACS), including Unstable Angina (UA) and Acute Myocardial Infarction (AMI), based on typical clinical symptoms, changes in electrocardiographic (ECG) readings, and elevated cardiac biomarkers.
3. Patients who underwent coronary angiography confirming coronary artery stenosis and opted for PCI treatment instead of coronary artery bypass grafting (CABG).
4. Patients who are under long-term follow-up.

Exclusion Criteria

1. Patients with rheumatic heart disease, valvular heart disease, or congenital heart disease.
2. Patients with malignant tumors or hematologic diseases.
3. Patients with severe liver or kidney dysfunction or pulmonary heart disease.
4. Patients with a life expectancy of less than one year due to terminal illnesses such as advanced cancer or chronic kidney disease requiring dialysis.
5. Patients whose health is severely impacted by acute infections.

Primary outcomes:
measure: Death
timeFrame: 10 years
Secondary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 10 years
measure: Major adverse cardiovascular and cerebrovascular events (MACCE）
timeFrame: 10 years
measure: revascularization of the target vesse
timeFrame: 10 years
measure: episodes of unstable angina necessitating medical intervention
timeFrame: 10 years
measure: hospitalization for acute heart failure classified as Killip Class IV
timeFrame: 10 years
measure: non-fatal myocardial infarction
timeFrame: 10 years
measure: cerebrovascular events
timeFrame: 10 years
Other outcomes:
Locations:
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medicial University
state: Xinjiang
Study officials:
affiliation: Xinjiang Medical University
name: Xiang Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References: