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NCT02463604 Clinical Trial

Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography

Renal Insufficiency Clinical Trial

— PREPARE  

Official title:
Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02463604
Other study ID # 2014-A01281-46
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date March 24, 2017

Study information
Verified date June 2018
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast medium-induced nephropathy in a population of high risk patients undergoing coronary angiography. Half of participants will receive a preconditioning procedure while the other half will receive a sham procedure.

Description:

Contrast medium-induced nephropathy has a big impact on clinical outcomes in patients suffering from renal insufficiency who undergo percutaneous coronary interventions.

Remote ischemic preconditioning is proved to protect myocardium in patients undergoing percutaneous coronary angiography.

We will evaluate the effect of remote preconditioning on renal protection.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date March 24, 2017
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

1. Patient headed to coronary angiography

2. Glomerular filtration rate :

- = 40ml/min/1,73m² (MDRD equation)

- or = 60ml/min/1,73m² (MDRD equation) with 1 additional risk factor : age > 75 years, NYHA = III/IV, diabetes mellitus

3. Signed informed consent

Exclusion Criteria:

1. Preoperative assessment / dilated cardiomyopathy assessment

2. Acute ST-segment elevation myocardial infarction

3. Cardiogenic shock requiring pressor amine or systolic blood pressure <80mmHg

4. Resuscitation after cardiac arrest

5. Intra-aortic balloon pump

6. Contraindication for the repeted use of an upper-arm pressure cuff

7. Extra-renal epuration

8. No health insurance coverage

9. Legal incapacity (patients under tutorship, curatorship or judicial protection)

10. Patient enrolled in another interventional trial or being in a washout period

11. Incapacity/impossibility to undergo 12-month follow-up

12. Patient refusal

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Coronary Angiography
Coronary angiography is performed following usual site standards

Locations
Country Name City State
France UH Angers - Cardiology ward Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Increase in serum creatinin level (=25% or 0,5mg/dL) Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy 48h after coronary angiography
Secondary Serum creatinin level is measured 12 months after coronary angiography and major adverse events are collected to assess long-term effects of remote ischemic preconditioning on renal function 12 months after coronary angiography
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