Condition category
Urological and Genital Diseases
Date applied
07/05/2009
Date assigned
15/07/2009
Last edited
06/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Periaswamy Vealavan

ORCID ID

Contact details

Liverpool Heart and Chest Hospital NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
periaswamy.velavan@lhch.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

805

Study information

Scientific title

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

Acronym

CONNECT

Study hypothesis

1. We hypothesise that N-acetylcysteine antioxidant prophylaxis prevents deterioration of renal impairment and may improve survival
2. We also hypothesise that use of iso-osmolar contrast media prevents deterioration of renal function in patients at high risk of contrast-induced nephropathy (CIN)

Ethics approval

Submitted via Integrated Research Application System (IRAS) – approval pending as of 07/05/2009

Study design

Randomised controlled open-label trial with 2 x 2 factorial design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Kidney function impairment/coronary artery disease/contrast-induced nephropathy

Intervention

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 to receive prophylactic N-acetylcysteine or not, with or without iso- and low-osmolar contrast media.

Study arms:
Arm 1: iso-osmolar contrast media
Arm 2: iso-osmolar contrast media + N-acetylcysteine
Arm 3: low-osmolar contrast media
Arm 4: low-osmolar contrast media + N-acetylcysteine

N-acetylcysteine will be given with a loading dose of 1,200 mg orally prior to the procedure on the day followed by 1,200 mg bulk oral dose for a total of four times (up to 48 hours) after the procedure.

Updated 06/08/2014: this trial was stopped before recruitment began in 2011 due to changing practices and procedures, lack of funding and resources and time availability.

Intervention type

Drug

Phase

Not Applicable

Drug names

N-acetylcysteine

Primary outcome measures

eGFR at 6 months

Secondary outcome measures

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.

Overall trial start date

01/07/2009

Overall trial end date

30/06/2011

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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)

Recruitment start date

01/07/2009

Recruitment end date

30/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Liverpool Heart and Chest Hospital NHS Trust
Liverpool
L14 3PE
United Kingdom

Sponsor information

Organisation

Liverpool Heart and Chest Hospital NHS Trust (UK)

Sponsor details

Thomas Drive
Liverpool
L14 3PE
United Kingdom

Sponsor type

Government

Website

http://www.lhch.nhs.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Liverpool Heart and Chest Hospital (UK) - Internal Charitable Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Covidien UK Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes