NCT02356510

Brief Summary

The current guidelines still recommend emergent PCI of the culprit lesion and state that primary PCI should be limited to the culprit vessel with the exception of cardiogenic shock and persistent ischaemia after PCI of the supposed culprit lesion. This recommendation is based on a high number of studies. However, several studies are present about the safety and efficacy of non-culprit vessel PCI during acute MI. Nowadays, the debate is increasingly going on about the PCI of the non-culprit arteries during the index event with newer prospective randomized studies. Besides, it is still unclear for the culprit artery whether to treat only the culprit lesion or all the other lesions in the culprit vessel during the index event. The present report describes a retrospective comparison between the two strategies during primary PCI for STEMI, looking for their influence on the clinical and angiographic course of the patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
637

participants targeted

Target at P75+ for all trials

Status
completed

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

June 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

8 months

First QC Date

February 1, 2015

Last Update Submit

February 4, 2015

Conditions

Keywords

myocardial infarctionTIMI flowculprit lesionculprit vessel

Outcome Measures

Primary Outcomes (1)

  • MACE

    18 months

Study Arms (2)

Culprit lesion

Patients who underwent culprit lesion only PCI during primary intervention

Procedure: Primary PCI

Culprit vessel

Patients who underwent culprit lesion only PCI during primary intervention

Procedure: Primary PCI

Interventions

Primary PCIPROCEDURE
Culprit lesionCulprit vessel

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This multi-centre retrospective study included patients from 3 high-volume primary PCI centres in Turkey. A total number of 5512 patients underwent emergent PCI for acute STEMI between January 2011 and December 2013. From this patient population, patients were looked for the presence of an additional lesion to the culprit lesion (CL). Additional lesion was defined as the presence of an angiographically severe (≥70%) lesion other than the CL either proximal or distal to it in the same coronary artery after the distal flow was observed most commonly as a result of guide-wire passage or PTCA of the total occlusion.

You may qualify if:

  • Patients who underwent primary PCI for acute STEMI and had \>1 lesion in the culprit artery

You may not qualify if:

  • Presence of LMCA lesion
  • Cardiogenic shock
  • Previous CABG operation
  • Decision for CABG operation after primary PCI
  • Severe valvular disease including aortic stenosis of mitral insufficiency
  • Severe kidney disease (serum creatinine \>2.5 mg/dl or patients on maintenance hemodialysis)
  • Rejection of second PCI by the patient after the index event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffessor of Cardiology, Head of Department

Study Record Dates

First Submitted

February 1, 2015

First Posted

February 5, 2015

Study Start

June 1, 2014

Primary Completion

February 1, 2015

Last Updated

February 5, 2015

Record last verified: 2015-02