NCT01399203

Brief Summary

To investigate the predictive value of the contrast media volume to creatinine clearance (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

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

Study Start

First participant enrolled

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 3, 2011

Status Verified

January 1, 2010

Enrollment Period

1.7 years

First QC Date

July 19, 2011

Last Update Submit

August 2, 2011

Conditions

Contrast Induced Nephropathy

Keywords

contrast-induced nephropathycontrast mediumcreatinine clearancepercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • Contrast-Induced Nephropathy

    Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure

    48-72 h

Secondary Outcomes (1)

  • Major adverse clinical events

    1 year

Study Arms (1)

percutaneous coronary intervention

The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention

You may qualify if:

  • patients who agreed to stay in the hospital for 2-3 days after percutaneous coronary intervention
  • provided written informed consent
  • Creatinine Clearance:15-60ml/min

You may not qualify if:

  • pregnancy
  • lactation
  • intravascular administration of an contrast medium within the previous seven days
  • treatment with metformin
  • aminoglycosides
  • N-acetylcysteine (NAC)
  • nonsteroidal anti-inflammatory drugs within the previous 48 h
  • intake of nephrotoxic drugs within the previous seven days
  • history of serious reactions to contrast mediums
  • severe concomitant disease
  • renal transplantation , or end-stage renal disease necessitating dialysis patients who died during percutaneous coronary intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ning Tan

Guangzhou, Guangdong, 510100, China

RECRUITING

Study Officials

  • Yong Liu, MD

    Guangdong Provincial People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Ning Tan, MD

CONTACT

86-20-83819161tanning100@126.com

Yong Liu, MD

CONTACT

86-15920172292liuyongyisheng@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 21, 2011

Study Start

January 1, 2010

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

August 3, 2011

Record last verified: 2010-01

Locations

CN(1)