NCT02833636

Brief Summary

The age, creatinine, and ejection fraction (ACEF) score has been used to evaluate the clinical prognostic to patients who underwent PCI. However, it is not known if ACEF score could evaluate the prognostic of recanalization of non-infarct-related coronary arteries (non-IRA) chronic total occlusions (CTO) in patients who successful underwent primary PCI. The objectivity of current study was to assess the prognostic value of ACEF score in acute ST-segment elevation myocardial infarction (STEMI) patients with non-IRA CTO after successful primary PCI.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,952

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than 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

January 1, 2006

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

8.9 years

First QC Date

July 11, 2016

Last Update Submit

July 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary end point

    Primary end point in the current study was a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven coronary revascularization and hospitalization for heart failure at 1year.

    1 year

Study Arms (2)

Successful CTO-PCI group

low ACEF score \<1.215 (n = 79), intermediate ACEF score from 1.215 to 1.493 (n=70), and high ACEF score≥1.493 (n=72)

Procedure: ACEF score

Failed/non-attempted CTO-PCI group

low ACEF score\<1.215 (n=45), intermediate ACEF score from 1.215 to 1.493 (n=57), and high ACEF score≥1.493 (n=54).

Procedure: ACEF score

Interventions

ACEF scorePROCEDURE
Failed/non-attempted CTO-PCI groupSuccessful CTO-PCI group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between January 2006 to December 2013, a total of 2952 consecutive and unselected acute STEMI patients were admitted to our hospital and treated with successful primary PCI.

Among the 2952 patients with STEMI successful treatment by PCI, 395 patients (13.4%) had a non-IRA CTO lesion. 18 patients were excluded from current study as they death within 7 days (n=6) or were not to follow-up (n=7). Due to unavailability of ejection fraction or renal function before CTO-PCI, ACEF score could not be calculated in 5 patients. The remaining 377 patients (95.4%) were finally analyzed in the study. 279 patients performed a staged CTO-PCI attempt(ranging 7-28 days) and was successful in 221 of them. Due to low possibility of PCI success or patients refused to perform PCI, 98 patients did not undergo the PCI attempt. The patients were then divided into successful CTO-PCI group (221 patients) and failed/ non-attempted CTO-PCI group (156 patients). \-

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 14, 2016

Study Start

January 1, 2006

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 14, 2016

Record last verified: 2016-07