Impact of OCT on Outcomes in AMI

February 23, 2022 updated by: Jincheng Guo, Beijing Luhe Hospital

Impact of Optical Coherence Tomography on Long-term Clincal Outcomes in Patients With Acute Myocardial Infarction

This protocol describes a retrospective, single-center study intended to test the impact of optical coherence tomography(OCT) on long term clincical outcomes in patients with acute myocardial infarction(AMI). All the patients will be followed by intracoronary OCT at medium follow-up of 3 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1600

Contacts and Locations

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

Study Contact

  • Name: Jincheng Guo, M.D.
  • Phone Number: 8610-13521968844
  • Email: guojcmd@126.com

Study Locations

  • China
      • Beijing, China, 100000
        • Recruiting
        • Beijing Luhe hospital
        • Contact:
          • Jincheng Guo, M.D.
          • Phone Number: 8610-13521968844

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In this retrospective study, all the patients ≥18yesrs with AMI enrolled was devided into 2 groups, the primary endpoint will be major adverse cardiovascular events at least 3 years clinical follow up.

Description

Inclusion Criteria:

  • Age≥18 years old
  • Patients undergo cardiac catheterization and percutaneous coronary intervention(PCI) for AMI(STEMI or NSTEMI) ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction, symptoms onset≤ 24h.NSTEMI was defined as elevated troponin levels and the absence of ST elevation at the time of diagnosis, PCI was performed within 24hours after symtoms onset.
  • Sufficient quality of the OCT recording allowing for CoreLab analysis.

Exclusion Criteria:

  • ostial of Left main disease
  • Cardiogenic shock or severe hemodynamic instability
  • Severe renal insufficiency (creatinine clearance ≤30 mL/min)
  • Bacteraemia or septicaemia
  • Severe coagulation disorders
  • Patients with life expectancy less than 1 year
  • Patients who refuse to sign the informed consent form

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OCT guided group
Device: OCT guided coronary intervention
patients were divided into two groups,on OCT guided coronary group and coronary angiography guided group
angiography guided group
Device: OCT guided coronary intervention
patients were divided into two groups,on OCT guided coronary group and coronary angiography guided group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major adverse cardiovascular event
Time Frame: 3 year
including cardiovascualr death, myocardial infarction, and target lesion revascularization, target vessel revascularization
3 year

Collaborators and Investigators

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

Sponsor

Beijing Luhe 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)

January 1, 2016

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijngLH

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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