Prognosis of Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— MPCS-ACS  

Official title:

A Multicenter, Prospective Cohort Study Evaluating the Prognosis of Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05164601
• Other study ID #: xx20161107
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: Xinjiang Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The MPCS-ACS Study (Multicenter Prospective Cohort Study on Acute Coronary Syndrome) is a comprehensive, forward-looking research project designed to understand the prognostic outcomes of patients diagnosed with acute coronary syndrome. Leveraging a multicenter approach, the study aims to collect data from a diverse group of patients, thereby enhancing the generalizability and relevance of its findings. Upon patient enrollment, a range of information will be carefully gathered, including demographic details, clinical history, and key biochemical markers. The study also intends to document the various medication regimens prescribed during hospital stays to evaluate their impact on patient outcomes. A pivotal aspect of MPCS-ACS is its thorough follow-up protocol, where patients are regularly monitored to track their recovery progress and the occurrence of any subsequent cardiovascular events after discharge. This methodical follow-up is designed to yield critical insights into the long-term prognosis of patients with acute coronary syndrome, ultimately aiding in the refinement of treatment approaches and elevating the standard of patient care across all participating centers.

Description:

The Multicenter Acute Coronary Syndrome Prognosis Cohort Study (MPCS-ACS) is an extensive, longitudinal research initiative designed to explore the prognostic outcomes of patients diagnosed with acute coronary syndrome (ACS) across various healthcare settings. This collaborative effort will involve numerous hospitals and aims to capture and analyze data from ACS patients admitted from June 1, 2016, to May 31, 2021.

Data collection will encompass a wide array of variables, highlighting therapeutic interventions, biochemical markers pertinent to ACS and its management, alongside essential demographic and clinical history information. This initiative seeks to thoroughly understand the treatment dynamics for ACS during this timeframe and evaluate their efficacy.

Follow-up procedures are integral to the MPCS-ACS, featuring routine evaluations every six months to a year after patients are discharged. These check-ins will employ both direct interactions and telecommunication to maintain a strong connection with participants, catering to those unable to visit the hospitals. This approach is designed to enhance participation rates and data quality, underpinning the study's credibility and the significance of its conclusions.

With its comprehensive methodology and operational rigor, the MPCS-ACS aspires to shed light on the prognostic determinants and outcomes of ACS patients, ultimately aiming to refine patient care strategies and elevate treatment benchmarks within the domain of cardiovascular healthcare.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22500
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2021
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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 that confirmed coronary artery stenosis and had PCI stents implanted.

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Other:
• No Intervention - Observational Only
Clinical Follow-Up

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	The First Affiliated Hospital of Xinjiang Medicial University	Ürümqi	Xinjiang

Sponsors (3)

Lead Sponsor	Collaborator
Xiang Xie	Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University, The Third Affiliated Hospital of Jinzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	All-cause mortality, Cardiac mortality	10 years
Secondary	Major adverse cardiovascular events (MACE)	cardiac death, non-fatal myocardial infarction, significant aortic pathologies including aortic dissection and rupture of aortic aneurysms, episodes of unstable angina necessitating medical intervention, hospitalization for acute heart failure classified as Killip Class IV, and revascularization of the target vessel.	10 years
Secondary	Major adverse cardiovascular and cerebrovascular events (MACCE)	cardiac death, non-fatal myocardial infarction, aortic events such as aortic dissection and aortic aneurysm rupture, episodes of unstable angina requiring medical intervention, hospitalization for acute heart failure assessed at Killip Class IV, target vessel revascularization, cerebrovascular events encompassing ischemic stroke, hemorrhagic stroke, transient ischemic attacks (TIAs) and subarachnoid hemorrhage.	10 years
Secondary	revascularization of the target vesse	Revascularization of the target vessel was performed using percutaneous coronary intervention (PCI).	10 years
Secondary	episodes of unstable angina necessitating medical intervention	Episodes of unstable angina requiring medical intervention were managed with urgent therapeutic measures.	10 years
Secondary	hospitalization for acute heart failure classified as Killip Class IV	hospitalization for acute heart failure classified as Killip Class IV	10 years
Secondary	non-fatal myocardial infarction	non-fatal myocardial infarction	10 years
Secondary	cerebrovascular events	ischemic stroke, hemorrhagic stroke, transient ischemic attacks (TIAs) and subarachnoid hemorrhage.	10 years