A randomised factorial trial of N-acetylcysteine prophylaxis and iso-osmolar versus low-osmolar contrast media on kidney function in patients at risk of contrast induced nephropathy following cardiac catheterisation for percutaneous coronary interventions - the CON NEC T” trial - CONNECT

• Conditions: Contrast-induced nephropathy following cardiac catheterisation; MedDRA version: 12.1Level: LLTClassification code 10010836Term: Contrast media reaction; MedDRA version: 12.1Level: LLTClassification code 10066973Term: Contrast media allergy; MedDRA version: 12.1Level: LLTClassification code 10029151Term: Nephropathy

• Registration Number: EUCTR2009-011175-70-GB
• Lead Sponsor: iverpool Heart and Chest Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

eGFR < 60 ml/m (as calculated by modified MDRD equation with local laboratory correction factor)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who had coronary angiography or other procedure with contrast exposure (CTPA etc.) within 2 weeks of PCI
2. Unable to consent
3. Patients undergoing angiographic investigations as a prelude to planned cardiac surgery
4. Cardiogenic shock
5. Unlikely to attend for follow up blood tests
6. Presence of non cardiac illness that might affect life expectancy
7. Any previous allergic reaction to contrast media or NAC

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified