NCT01372891

Brief Summary

The present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of contrast induced nephropathy (CIN) in the patients undergoing 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
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 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

Study Start

First participant enrolled

April 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

3 years

First QC Date

June 10, 2011

Last Update Submit

November 21, 2011

Conditions

Keywords

Contrast Induced Nephropathypercutaneous coronary interventions

Outcome Measures

Primary Outcomes (1)

  • increase in SCr 0.5 mg/dL(44.2 mol/L) from baseline

    samples will be collected at 24, 48 and 72 hours after PCI

    3 days

Secondary Outcomes (1)

  • a 25% increase in SCr from baseline

    3 days

Study Arms (1)

Patients underging PCI

Eligibility Criteria

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

This study enrolls a group of patients\> 18 who have ST elevation myocardial infarction (STEMI) undergoing primary PCI.

You may qualify if:

  • All patients \> 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study.

You may not qualify if:

  • The end-stage renal failure
  • The patients who are relieving dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum,urine

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Ling Tao, M.D Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 14, 2011

Study Start

April 1, 2010

Primary Completion

April 1, 2013

Study Completion

December 1, 2014

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations