NCT00317252

Brief Summary

The purpose of this study is to determine if patients should stop taking their angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) around the time of their angiogram in order to prevent contrast induced nephropathy (CIN).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

Enrollment Period

5.7 years

First QC Date

April 20, 2006

Last Update Submit

October 19, 2012

Conditions

Kidney Failure

Keywords

contrast induced nephropathycontrast nephropathycontrast mediakidney diseasesangiotensin converting enzyme inhibitors

Outcome Measures

Primary Outcomes (1)

  • Contrast induced nephropathy (creatinine rise of 44umol/L or 25% compared to the pre-randomization creatinine level) at 48-96hrs

    48 - 96 hours post-cardiac catheterization

Secondary Outcomes (3)

  • Change in serum creatinine at 48-96hrs

    48 - 96 hours post-cardiac catheterization

  • Change in creatinine clearance at 48-96hrs

    48 - 96 hours post-cardiac catheterization

  • Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-96hrs.

    48 - 96 hours post-cardiac catheterization

Study Arms (2)

Hold ACEI or ARB

EXPERIMENTAL

Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held \>= 24 hours pre-cardiac catheterization and restarted post-catheterization after creatinine measurement (48-96 hours post)

Drug: Hold ACEI or ARB

Continue ACE1 or ARB

OTHER

Randomized to continue on prescribed ACE1 or ARB

Drug: Hold ACEI or ARB

Interventions

Hold ACEI or ARBDRUG

Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held at least 24 hours pre-cardiac catheterization and restarted 48-96 hours post-catheterization (after creatinine measurement)

Also known as: Includes all ACE inhibitors or ARBs
Continue ACE1 or ARBHold ACEI or ARB

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for Angiography in \>= 24hrs from enrolment
  • Documented Cr \>= 150 within 3 months before cardiac catheterization AND/OR documented Cr \>= 132umol/L within 1 week Before Cardiac Catheterization
  • Currently Taking an ACE Inhibitor

You may not qualify if:

  • Patients with end stage renal disease (for example, patient on dialysis)
  • Emergency Cardiac Catheterization with insufficient time to hold the ACEI
  • Acute Pulmonary Edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

  • Bainey KR, Rahim S, Etherington K, Rokoss ML, Natarajan MK, Velianou JL, Brons S, Mehta SR; CAPTAIN Investigators. Effects of withdrawing vs continuing renin-angiotensin blockers on incidence of acute kidney injury in patients with renal insufficiency undergoing cardiac catheterization: Results from the Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker and Contrast Induced Nephropathy in Patients Receiving Cardiac Catheterization (CAPTAIN) trial. Am Heart J. 2015 Jul;170(1):110-6. doi: 10.1016/j.ahj.2015.04.019. Epub 2015 Apr 18.

    PMID: 26093871DERIVED

MeSH Terms

Conditions

Renal InsufficiencyKidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Shamir R Mehta, MD MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

April 20, 2006

First Posted

April 24, 2006

Study Start

July 1, 2006

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 22, 2012

Record last verified: 2012-10

Locations

CA(1)