Predictive Value of Cardiovascular Magnetic Resonance Related Parameters in STEMI Patients After Primary PCI for Adverse Left Ventricular Remodeling and Major Adverse Cardiovascular Events

April 3, 2022 updated by: Qian geng

Predictors of Cardiovascular Magnetic Resonancerelated Parameters: Intramyocardial Hemorrhage, Microvascular Obstruction , Area at Risk and Strain Related Parameters, and Their Effects on Adverse Ventricular Remodeling and MACEs in STEMI Patients After Primary PCI

This study aim to investigate the predictive value of CMR parameters: infarct size (IS), intramyocardial hemorrhage, microvascular obstruction, area at risk and CMR derived strain parameters with the Major Adverse Cardiovascular Events (MACEs) and myocardial remodeling afterinfarction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators will enroll 500 patients with STEMI after PCI who were admitted to the Chinese PLA General Hospital and other eight hospitals across China: Wuhan Asia Heart Hospital; the First People's Hospital of Yunlin; Chaoyang Hospital, Capital Medical University; Hainan Hospital of PLA General Hospital; the Second Affiliated Hospital of Nanchang University; the Second Hospital of Hebei Medical University; Guizhou Provincial People's Hospital; Affiliated Hospital of Zunyi Medical College between January 2014 and December 2019. CMR was performed at 7 days and 6 months after primary PCI to assess the final infarction size(IS), microvascular obstruction (MVO), intramyocardial hemorrhage(IMH), area at risk (AAR) and related strain parameters. All patients will be followed up by 5 years after adimission. Cardiovascular events concluded stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction, and all cause death. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.

Study Type

Observational

Enrollment (Actual)

500

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
      • Peking, Beijing, China, 100853
        • Chinese PLA General Hospital

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Investigators will enroll 500 patients with STEMI after PCI who were admitted to the Chinese PLA General Hospital and other eight hospitals across China between January 2016 and January 2019. CMR was performed at 7 days and 6 months after primary PCI to assess the final infarction size, microvascular obstruction (MVO), area at risk (AAR) and related strain parameters. All patients will be followed up by 5 years after addimission index.

Description

Inclusion Criteria:

  1. Age 18-80 years.
  2. clinically diagnosed ST-segment elevation myocardial infarction.
  3. Intended to undergo emergency PCI.
  4. Voluntary enrollment and signed informed consent form.

Exclusion Criteria:

  1. undergoing revascularization (PCI or coronary artery bypass grafting (CABG)) within 6 months;
  2. Pregnant and breastfeeding women;
  3. Contraindications of CMR: implanted cardiac defibrillator (ICD), claustrophobia, allergy to gadolinium
  4. Liver or kidney failure;
  5. Malignant tumor;
  6. Unconscious at present;
  7. systolic blood pressure (SBP) less than 80 mmHg;
  8. Patients with bundle branch or fascicular block, insufficient ECG data.
  9. Patients with other significant abnormal signs, laboratory tests and clinical disease are unsuitable for participation in the study accessed by clinicians.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACEs
Time Frame: follow up in five years
MACEs concluding All-cause mortality, stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction
follow up in five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular remodeling
Time Frame: 6 month after PCI
Increase of LVEDV >20%
6 month after PCI
Contrast-induced acute kidney injury
Time Frame: 48 to 72 hours after PCI
25% or 0.5 mg/dl increase in serum creatinine
48 to 72 hours after PCI

Collaborators and Investigators

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

Sponsor

Qian geng

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2014

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 3, 2022

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qgeng-2021-2-16

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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