NCT03164681

Brief Summary

Contrast Induced Nephropathy is an acute renal insufficiency defined as a 25% or 0.5 mg/dl increase over the baseline of the serum creatinine level 24 h to 72 h after intravascular administration of a contrast agent.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

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

May 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
12 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

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

12 months

First QC Date

May 22, 2017

Last Update Submit

May 23, 2017

Conditions

Contrast-induced Nephropathy

Keywords

sheerly

Outcome Measures

Primary Outcomes (1)

  • Contrast Induced Nephropathy

    Percentage of patients with raised serum creatinine 25% or 0.5 mg/dl over baseline serum creatinine within 48 hour after contrast administration

    48 Hours

Eligibility Criteria

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

patients who underwent percutaneous coronary intervention

You may qualify if:

  • Consecutive patients who underwent percutaneous coronary intervention either elective or emergency.

You may not qualify if:

  • End stage renal disease with glomerular filtration rate less than 30 ml/1.73.
  • Patient known allergy to contrast agents.
  • Left ventricular ejection fraction below 30%.
  • Presence of infection
  • A recent history of contrast administration in the previous month.
  • Patient known to have thyroid disease.
  • History of malignancy.
  • Patient known to have Autoimmune disease.
  • Decompensated liver cirrhosis
  • Cardiogenic shock.
  • Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Mehran R, Nikolsky E. Contrast-induced nephropathy: definition, epidemiology, and patients at risk. Kidney Int Suppl. 2006 Apr;(100):S11-5. doi: 10.1038/sj.ki.5000368.

    PMID: 16612394BACKGROUND

  • Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043.

    PMID: 15519007BACKGROUND

  • McCullough PA. Contrast-induced acute kidney injury. J Am Coll Cardiol. 2008 Apr 15;51(15):1419-28. doi: 10.1016/j.jacc.2007.12.035.

    PMID: 18402894BACKGROUND

  • Bartholomew BA, Harjai KJ, Dukkipati S, Boura JA, Yerkey MW, Glazier S, Grines CL, O'Neill WW. Impact of nephropathy after percutaneous coronary intervention and a method for risk stratification. Am J Cardiol. 2004 Jun 15;93(12):1515-9. doi: 10.1016/j.amjcard.2004.03.008.

    PMID: 15194023BACKGROUND

  • Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002 May;39(5):930-6. doi: 10.1053/ajkd.2002.32766.

    PMID: 11979336BACKGROUND

  • Tepel M, Aspelin P, Lameire N. Contrast-induced nephropathy: a clinical and evidence-based approach. Circulation. 2006 Apr 11;113(14):1799-806. doi: 10.1161/CIRCULATIONAHA.105.595090. No abstract available.

    PMID: 16606801RESULT

  • Seeliger E, Sendeski M, Rihal CS, Persson PB. Contrast-induced kidney injury: mechanisms, risk factors, and prevention. Eur Heart J. 2012 Aug;33(16):2007-15. doi: 10.1093/eurheartj/ehr494. Epub 2012 Jan 19.

    PMID: 22267241RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood ,serum,

Study Officials

  • sherly boshra

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Tohamy, MD

CONTACT

01227370775proftohammy@yahoo.com

Mostafa Mohammed, Master

CONTACT

01013701057Mostafafaisal2017@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 24, 2017

Study Start

December 1, 2017

Primary Completion

November 30, 2018

Study Completion

December 30, 2018

Last Updated

May 24, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share