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Clinical Trials/EUCTR2011-003611-37-IT
EUCTR2011-003611-37-IT
Active, not recruiting
Not Applicable

PRevEntion of cardiac and Vascular pEriprocedural complications in patients undergoiNg coronary angiography or angioplasTy: hydratation vs carbonates to prevent Contrast-Induced Nephropathy in patients undergoing coronary angiography or intervention at risk for Heart Failure (PREVENT-CIN HF). A prospective randomized trial. - PREVENT-CINHF

AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA' DI NOVARA0 sites240 target enrollmentMarch 7, 2012
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ConditionsPatients undergoing coronary angiography or angioplastyMedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients undergoing coronary angiography or angioplasty
Sponsor
AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA' DI NOVARA
Enrollment
240
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 7, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA' DI NOVARA

Eligibility Criteria

Inclusion Criteria

  • •Consecutive patients undergoing coronary angiography, followed or not by coronary revascularization, at Cath Lab of U.O. of Universitary Cardiology AOU Maggiore della Carità”, Novara.
  • •An estimated glomerular filtration rate (GFR) of 60 mL/min or less (calculated by applying the Cockroft\-Gault formula) before undergoing coronary angiography.
  • •An estimated ejection fraction\<40% (transthoracic echocardiogram).
  • •Severe mitro\-aortic valve disease estimated by transthoracic echocardiogram also in the presence of an ejection fraction \>40%.
  • •Recent episode af acute pulmonary edema.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 140
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •Inability to obtain consent.
  • •Age lower than 18 years old.
  • •Pregnancy.
  • •Coronary angiography/or revascularisation in emergency.
  • •Serious comorbility (shock, cardiac arrest, trauma, etc.).
  • •An estimated ejection fraction \>40% (transthoracic echocardiogram).
  • •Hystory of contrast intolerance.
  • •Kidney transplant.
  • •Periprocedural complications within 48h after the procedure.

Outcomes

Primary Outcomes

Not specified

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