Cto, Acef ScoreNCT02833636
Prognostic Value of The Age, Creatinine, and Ejection Fraction Score for Non-infarct-related Chronic Total Occlusion Revascularization After Primary Percutaneous Intervention in Acute ST-elevation Myocardial Infarction Patients: A Retrospective Study
An observational study of Cto, Acef Score, run by Xibei Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cto, Acef Score
- What is being tested?
- ACEF score
- Type of treatment
- Surgery or procedure
- How many people
- 2,952 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
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About this study
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.
- Conditions
- Cto, Acef Score
- Being tested
- ACEF score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACEF scoreProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Procedure: ACEF score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJan 2006
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cto, Acef ScoreStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,952 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xibei Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833636
- Sponsor's protocol ID
- 2010cto-1
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 14 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of The Age, Creatinine, and Ejection Fraction Score for Non-infarct-related Chronic Total Occlusion Revascularization After Primary Percutaneous Intervention in Acute ST-elevation Myocardial Infarction Patients: A Retrospective Study
- ClinicalTrials.gov ID
- NCT02833636
- Acronym / sponsor ID
- 2010cto-1
- Conditions
- Cto, Acef Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,952 participants (actual)
- Lead sponsor
- Xibei HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful CTO-PCI group | – | Procedure: ACEF scorelow 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) |
| Failed/non-attempted CTO-PCI group | – | Procedure: ACEF scorelow 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACEF score | Procedure or surgery | Failed/non-attempted CTO-PCI group, Successful CTO-PCI group |
Primary outcome
Primary end point
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cto, Acef Score, run by Xibei Hospital.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary end point (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.