Clinical Study of CMR to Evaluate the Effect of Ivabradine on the Improvement of Left Ventricular Remodeling in STEMI Patients After Primary PCI

April 21, 2022 updated by: Qian geng
This study aim to investigate the effect of ivabradine on reducing infarct size and improving left ventricular remodeling after in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators will enroll 240 patients with STEMI who were admitted to the Chinese PLA General Hospital between October 2020 and October 2021，the investigators randomly assign eligible patients in a 1:1 ratio to either ivabradine or oral placebo befor primary PCI. The treatment was initiated after primary PCI with ivabradine orally for 6 months. Primary end point of the study was the area of infarct size measured by cardiac magnetic resonance (CMR). Cardiovascular events concluding 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

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

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
        • Recruiting
        • Chinese People's Liberation Army General Hospital
        • Contact:
        • Contact:

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

Description

Inclusion Criteria:

  • STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T
  • patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions

Exclusion Criteria:

  • had once treated by ivabradine
  • history of myocardial infarction
  • mechanical complications
  • Unable to perform myocardial MRI
  • liver and kidney failure
  • malignant tumor
  • unconscious

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: The control group
Experimental: Ivabradine group
The starting dose is 5 mg twice a day. After 2 weeks of treatment, if the patient's resting heart rate continues to be higher than 70 beats per minute, increase the dose to 7.5 mg twice a day. If the patient's resting heart rate continues to be less than 50 beats per minute or symptoms related to bradycardia occur, reduce the dose to 2.5 mg
Drug: Ivabradine
The starting dose is 5 mg twice a day. Adjust the dose according to the actual situation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial infarct size according to MR delayed enhancement scan
Time Frame: 7 days after PCI
Two experienced MRI cardiologists analyzed the delayed enhancement image enhancement area of MRI to obtain the area of myocardial infarction through the Segment v1.9 post-processing software
7 days after PCI
main cardiovascular events
Time Frame: follow up in 6 months
Acute heart failure, recurrence of myocardial infarction, death from all causes, stroke, cardiac death, recurrent myocardial infarction, recurrent target vascular revascularization, re-admission because of angina pectoris or heart failure
follow up in 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of the LVEF
Time Frame: follow up in 6 months
left ventricular ejection fraction (LVEF)
follow up in 6 months

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)

August 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

December 5, 2021

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qg-2021-12-01

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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