NCT02664246

Brief Summary

This review article have included about ten thousand patients undergoing percutaneous coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new risk factors and the protecting methods for these factors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 22, 2016

Last Update Submit

January 26, 2016

Conditions

Cardio-Renal Syndrome

Keywords

contrast-induced nephropathyPercutaneous coronary interventionrisk factorsincidence

Outcome Measures

Primary Outcomes (1)

  • Contrast induced nephropathy postoperation

    peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7

    7 days

Secondary Outcomes (1)

  • Composite measure of dialysis or main cardiovascular events

    90 days

Interventions

percutaneous coronary interventionDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015

You may qualify if:

  • congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) \<= 50%;
  • moderate to severe chronic kidney disease was defined as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment;
  • patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.

You may not qualify if:

  • hemodialysis-dependent patients;
  • complicated with severe short-term progressive disease;
  • Patients \< 18 years;
  • pregnancy;
  • emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);
  • exposure to radiographic contrast media within the previous 7 days;
  • acute decompensated heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Tao SM, Wichmann JL, Schoepf UJ, Fuller SR, Lu GM, Zhang LJ. Contrast-induced nephropathy in CT: incidence, risk factors and strategies for prevention. Eur Radiol. 2016 Sep;26(9):3310-8. doi: 10.1007/s00330-015-4155-8. Epub 2015 Dec 18.

    PMID: 26685852BACKGROUND

  • Wichmann JL, Katzberg RW, Litwin SE, Zwerner PL, De Cecco CN, Vogl TJ, Costello P, Schoepf UJ. Contrast-Induced Nephropathy. Circulation. 2015 Nov 17;132(20):1931-6. doi: 10.1161/CIRCULATIONAHA.115.014672. No abstract available.

    PMID: 26572669BACKGROUND

  • Andreucci M, Faga T, Pisani A, Sabbatini M, Russo D, Michael A. Prevention of contrast-induced nephropathy through a knowledge of its pathogenesis and risk factors. ScientificWorldJournal. 2014;2014:823169. doi: 10.1155/2014/823169. Epub 2014 Nov 30.

    PMID: 25525625BACKGROUND

  • Qian G, Fu Z, Guo J, Cao F, Chen Y. Prevention of Contrast-Induced Nephropathy by Central Venous Pressure-Guided Fluid Administration in Chronic Kidney Disease and Congestive Heart Failure Patients. JACC Cardiovasc Interv. 2016 Jan 11;9(1):89-96. doi: 10.1016/j.jcin.2015.09.026. Epub 2015 Dec 9.

    PMID: 26685074BACKGROUND

MeSH Terms

Conditions

Cardio-Renal Syndrome

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Dai Yun Chen, MD

    Chinese PLA General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 27, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 27, 2016

Record last verified: 2016-01