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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02463604

Acronym

PREPARE

Enrollment

220

Registered

2015-06-04

Start date

2015-06-30

Completion date

2017-03-24

Last updated

2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Medium-induced Renal Insufficiency, Renal Insufficiency

Brief 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.

Detailed 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.

Interventions

PROCEDURECoronary Angiography

Coronary angiography is performed following usual site standards

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Increase in serum creatinin level (≥25% or 0,5mg/dL)	48h after coronary angiography	Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026