NCT03266458

Brief Summary

all patient presented with ST elevated myocardial infarction and underwent PPCI will be calculated with CHA2DS2-VASC score and contrast volume / creatinine clearance as apredictive value for Contrast induced nephropathy and the predictive value of these scores will be compared with the approved predictive value of MEHRAN score which is also will be calculated to every patient .

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
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

August 25, 2017

Last Update Submit

August 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Contrast induced nephropathy

    contrast induced nephropathy (CIN) defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl from baseline within 48 h after contrast exposure so we will follow up creatinine level according to the defenition .

    48 hours

Interventions

Urgent percutaneous coronary intervention for ST- elevation myocardial infarction patients.

Also known as: PPCI

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will include \> 210 patients ( calculated sample size) who have STEMI and undergoing PPCI in Cath lab of Orman university Heart Hospital of Assiut University starting from January 2018 .

You may qualify if:

  • All patients with STEMI who are eligible for primary PCI will be enrolled in the study.

You may not qualify if:

  • (1) If the coronary anatomy was not suitable for PCI. (2) If emergency bypass grafting was required. (3) Patients in chronic peritoneal or hemodialytic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, Egypt

Location

Related Publications (33)

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    BACKGROUND
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    PMID: 11345367BACKGROUND
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    PMID: 12517460BACKGROUND
  • Keeley EC, Hillis LD. Primary PCI for myocardial infarction with ST-segment elevation. N Engl J Med. 2007 Jan 4;356(1):47-54. doi: 10.1056/NEJMct063503. No abstract available.

    PMID: 17202455BACKGROUND
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    PMID: 18283206BACKGROUND
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    PMID: 18199862BACKGROUND
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    PMID: 15519007BACKGROUND
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    BACKGROUND
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    PMID: 9375704BACKGROUND
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    PMID: 15145097BACKGROUND
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  • Kurtul A, Yarlioglues M, Duran M. Predictive Value of CHA2DS2-VASC Score for Contrast-Induced Nephropathy After Percutaneous Coronary Intervention for Acute Coronary Syndrome. Am J Cardiol. 2017 Mar 15;119(6):819-825. doi: 10.1016/j.amjcard.2016.11.033. Epub 2016 Dec 18.

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  • Chen SL, Zhang J, Yei F, Zhu Z, Liu Z, Lin S, Chu J, Yan J, Zhang R, Kwan TW. Clinical outcomes of contrast-induced nephropathy in patients undergoing percutaneous coronary intervention: a prospective, multicenter, randomized study to analyze the effect of hydration and acetylcysteine. Int J Cardiol. 2008 Jun 6;126(3):407-13. doi: 10.1016/j.ijcard.2007.05.004. Epub 2007 Jul 24.

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Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at cardiology department at assiut university hospital

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 30, 2017

Study Start

January 1, 2018

Primary Completion

November 30, 2018

Study Completion

December 30, 2018

Last Updated

August 30, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations