NCT05266547

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

7 years

First QC Date

February 23, 2022

Last Update Submit

February 23, 2022

Conditions

Keywords

Tomography, Optical CoherenceSTEMINSTEMIMajor adverse cardiovascular event

Outcome Measures

Primary Outcomes (1)

  • major adverse cardiovascular event

    including cardiovascualr death, myocardial infarction, and target lesion revascularization, target vessel revascularization

    3 year

Study Arms (2)

OCT guided group

Device: OCT guided coronary intervention

angiography guided group

Device: OCT guided coronary intervention

Interventions

patients were divided into two groups,on OCT guided coronary group and coronary angiography guided group

OCT guided groupangiography guided group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Luhe Hospital

Beijing, 100000, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Jincheng Guo, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chairman of CCU

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 4, 2022

Study Start

January 1, 2016

Primary Completion

January 1, 2023

Study Completion

January 1, 2024

Last Updated

March 4, 2022

Record last verified: 2022-02

Locations