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OpenTrials
Completed

NCT Number: NCT04789564

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

cardiovascular magnetic resonance (CMR)

Diagnostic Test

Testing CMR on patients of 7 days and 6 months after myocardial infarction

Primary outcomes

  1. MACEs

    Time frame: follow up in five years

    MACEs concluding All-cause mortality, stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction

Secondary outcomes

  1. Left ventricular remodeling

    Time frame: 6 month after PCI

    Increase of LVEDV >20%

  2. Contrast-induced acute kidney injury

    Time frame: 48 to 72 hours after PCI

    25% or 0.5 mg/dl increase in serum creatinine

Sponsors and collaborators

Lead sponsor

Qian geng

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Mar 9, 2021
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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