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A randomised trial comparing two strategies for preventing kidney failure after angioplasty

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15027862
Enrollment
200
Registered
2009-07-15
Start date
2009-07-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Kidney function impairment/coronary artery disease/contrast-induced nephropathy Urological and Genital Diseases Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions

Interventions

All patients undergoing cardiac catheterisation with the intention of percutaneous coronary intervention (definite PCI or catheterisation +/- PCI) that meet the inclusion criteria will be randomised t

Sponsors

Liverpool Heart and Chest Hospital NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 18 years or over 2. Estimated glomerular filtration rate (eGFR) less than 60 ml/m (as calculated by modified Modification of Diet in Renal Disease [MDRD] equation with local laboratory correction factor)

Exclusion criteria

Exclusion criteria: 1. Patients who had coronary angiography or other procedure with contrast exposure (computed tomography pulmonary angiography [CTPA] etc.) within 2 weeks of percutaneous coronary intervention (PCI) 2. Unable to consent 3. Patient undergoing 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 N-acetylcysteine (NAC)

Design outcomes

Primary

MeasureTime frame
eGFR at 6 months

Secondary

MeasureTime frame
1. Contrast-induced nephropathy. Total duration of follow-up: 6 months. 2. eGFR at 14 days 3. Major Adverse Cardiovascular Events (MACE) ? death, myocardial infarction (MI), stroke, and repeat revascularisation. Total duration of follow-up: 6 months. 4. Renal replacement therapy. Total duration of follow-up: 6 months.

Countries

United Kingdom

Outcome results

None listed

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