Prognosis of Treated Acute Coronary Syndrome Patients: a Multicenter Study (MPCS-ACS)

January 30, 2025 updated by: Xiang Xie

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Xinjiang
      • Ürümqi, Xinjiang, China, 630000
        • The First Affiliated Hospital of Xinjiang Medical University
      • Ürümqi, Xinjiang, China, 830000
        • The First Affiliated Hospital of Xinjiang Medicial University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Acute Coronary Syndrome

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
AMI Patients Cohort
Other: No Intervention - Observational Only
Clinical Follow-Up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 10 years
All-cause mortality, Cardiac mortality
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events (MACE)
Time Frame: 10 years
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
Major adverse cardiovascular and cerebrovascular events (MACCE）
Time Frame: 10 years
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
revascularization of the target vesse
Time Frame: 10 years
Revascularization of the target vessel was performed using percutaneous coronary intervention (PCI).
10 years
episodes of unstable angina necessitating medical intervention
Time Frame: 10 years
Episodes of unstable angina requiring medical intervention were managed with urgent therapeutic measures.
10 years
hospitalization for acute heart failure classified as Killip Class IV
Time Frame: 10 years
hospitalization for acute heart failure classified as Killip Class IV
10 years
non-fatal myocardial infarction
Time Frame: 10 years
non-fatal myocardial infarction
10 years
cerebrovascular events
Time Frame: 10 years
ischemic stroke, hemorrhagic stroke, transient ischemic attacks (TIAs) and subarachnoid hemorrhage.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiang Xie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Third Affiliated Hospital of Jinzhou Medical University
Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiang Xie, PhD, Xinjiang Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • xx20161107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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