The Influence of Angiotensin Converting Enzyme Inhibitors... | NCT01071642

Studies
The Influence of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers on Renal Function in Patients Undergoing Non-emergent Coronary Angiography

NCT01071642

Sponsor

Soroka University Medical Center

Status

Completed

Last Update Posted

Jun 21, 2017Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Blood Pressure

Interventions

stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure
ACE/ARB stopped 24 hours before procedure and start immediately after

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Feb 18, 2010

First Submission Date that Met QC Criteria

Feb 18, 2010

First Posted Date

Feb 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2017

Last Update Posted Date

Jun 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Talya Wolak, senior doctor internal medicine department, Soroka University Medical CenterPrincipal Investigator

Lead Sponsor

Soroka University Medical CenterOTHER

Collaborators

Not provided

Description Module

Brief Summary

The aim of the current study is to evaluate prospectively whether concomitant administration of RAAS blockers (namely ACE-I and ARBs') influence the change in estimated GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
continue ace-i and arb's versus dicontinue	No Intervention
group b	Active Comparator	Drug: stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure
group c	Active Comparator	Drug: ACE/ARB stopped 24 hours before procedure and start immediately after

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure	Drug	ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure	group b

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in eGFR from baseline to 48 hours following the exposure to the contrast.		48 hours after exposure to the contrast

Secondary Outcomes

Measure	Description	Time Frame
1. Rate of eGFR decrease>25% from the baseline, 2. Length of hospitalization,		48-72 hours after exposure to contrast

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Age>18 years
2. Subjects on chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file)
3. Subjects planned to undergo non-emergent coronary angiography.
4. Signed informed consent

Exclusion Criteria:

1. eGFR<30 ml/min at baseline
2. Chronic utilization of NSAIDS and Cox-2 selective inhibitors
3. Chronic treatment with mineralocorticosteroid receptor blocker
4. Systolic blood pressure<90 mmHg
5. Planned staged (repeated) procedure within 48 hours
6. Administration of contrast within 14 days prior to the enrollment
7. contraindication to stop ACE-I or ARB'S

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Talya Wolak		Bear Sheva		8410	Israel

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.