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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011175-70-GB
Enrollment
Unknown
Registered
2009-04-16
Start date
2009-05-28
Completion date
Unknown
Last updated
2012-08-14

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

Conditions

Contrast-induced nephropathy following cardiac catheterisation MedDRA version: 12.1 Level: LLT Classification code 10010836 Term: Contrast media reaction MedDRA version: 12.1 Level: LLT Classification code 10066973 Term: Contrast media allergy MedDRA version: 12.1 Level: LLT Classification code 10029151 Term: Nephropathy

Interventions

Trade Name: Fluimucil Product Name: Fluimucil Product Code: R05CB01 Pharmaceutical Form: Tablet INN or Proposed INN: ACETYLCYSTEINE CAS Number: 616-91-1 Concentration unit: mg milligram(s) Concentrati

Sponsors

Liverpool Heart and Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: eGFR =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: The purpose of this proposal is to prospectively compare in a 2x2 factorial design the protective effects of prophylactic N-acetylcysteine induced by two different types of contrast medium in patients with impaired renal function undergoing PCI. ;Secondary Objective: It is hoped that this will establish whether N-acetylcysteine is beneficial in terms of preservation of residual renal function (estimated by glomerular filtration rate) and survival as assessed at 6 months. ;Primary end point(s): eGFR at 6 months—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026