Prognostic Value of Right Ventricular Myocardial Strain in Patients With Acute Myocardial Infarction

June 20, 2022 updated by: Peking University Third Hospital

Prognostic Value of Right Ventricular Myocardial Strain in Patients With Acute Myocardial Infarction With Different Infarction-related Vessels

For a long time, the right ventricle has been the "forgotten chamber", but with the deepening of people's understanding of the disease, right ventricular dysfunction has become an important factor to evaluate the disease progression and late prognosis of patients with AMI. Right ventricular myocardial strain derived from two-dimensional speckle tracking echocardiography is a new method for early evaluation of regional and global right ventricular systolic function, and its repeatability is much higher than that of LVEF. Acute inferior myocardial infarction is often caused by occlusion of the proximal middle segment of the right coronary artery. Many studies have confirmed that RVMS is an independent predictor of poor prognosis in patients with AIMI. However, 60% of the right ventricular systolic function is contributed by the left ventricle and interventricular septum, and the left anterior descending branch and the left circumflex branch are the main sources of blood supply to the left ventricle and interventricular septum, so in theory, non-RCA occlusion can also lead to varying degrees of right ventricular dysfunction. However, there are few studies on the role of RVMS in predicting the prognosis of AMI patients caused by non-RCA occlusion. Therefore, the purpose of this study is to prospectively study the value of dynamic changes of RVMS in predicting the prognosis of patients with acute myocardial infarction with different infarct-related vessels, in order to provide more clinical reference information for the diagnosis and treatment of AMI.

Study Overview

Status

Status

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

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

In this study, 200 patients with acute myocardial infarction treated in Peking University Third Hospital from March 2022 to March 2024 were enrolled in this study. the parameters of myocardial enzymes, blood lipids and echocardiography were collected at the acute stage, 2 weeks and 6 months after discharge, and were followed up for two year. The echocardiographic parameters and MACE of patients with acute myocardial infarction with different infarction related vessels were compared. This shows the significance of right ventricular myocardial strain in predicting the prognosis of patients with acute myocardial infarction.

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 (Anticipated)

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.
200

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
    • Beijing
      • Beijing, Beijing, China, 100191

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

35 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with acute myocardial infarction undergoing primary percutaneous coronary intervention are included.

Description

Inclusion Criteria:

  1. Males and females were between 35 and 85 years old;
  2. coronary artery disease underwent emergency PCI for NSTEMI or primary PCI for STEMI;
  3. coronary artery type was right coronary dominance;
  4. regular follow-up for 2 year.

Exclusion Criteria:

  1. Patients who cannot complete 2D speckle tracking imaging;
  2. patients with severe valvular disease, cardiomyopathy, or congenital heart disease; severe liver and kidney insufficiency or chronic respiratory disease;
  3. previous PCI or CABG;
  4. coronary artery type: Left crown dominance.

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: Cohort
  • 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.
acute myocardia infarction patients with right coronary artery occlusion
Other: two-dimensional speckle tracking echocardiography
Two-dimensional speckle tracking echocardiography is used to assess cardiac function in all enrolled patients
acute myocardia infarction patients with non-right coronary artery occlusion
Other: two-dimensional speckle tracking echocardiography
Two-dimensional speckle tracking echocardiography is used to assess cardiac function in all enrolled patients

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
Major Adverse Cardiovascular Events
Time Frame: 2 years
Nonfatal stroke, nonfatal myocardial infarction, target vessel requiring revascularization, death
2 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.
Peking University Third Hospital

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.
October 1, 2021

Primary Completion (Anticipated)

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 30, 2024

Study Completion (Anticipated)

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.
October 30, 2024

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).
May 31, 2022

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.
May 31, 2022

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.
June 3, 2022

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.
June 24, 2022

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.
June 20, 2022

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.
March 1, 2022

More Information

Terms related to this study

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.
  • M2022093

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

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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