CompletedNCT00827788CONTRAST-AMIUpdated Nov 16, 2010

Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)

A Phase 4 interventional study of Iodixanol and Iopromide in Contrast Induced Nephropathy and Acute Myocardial Infarction, sponsored by Ospedale San Donato. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-16.

Sponsored by Ospedale San Donato · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 432
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI.

Read the detailed description

This is a multicentric randomized comparison between iso-osmolar and ipo-osmolar contrast agents in patients treated with primary PCI with the evaluation of contrast-induced nephropathy incidence and myocardial tissue reperfusion. The study was designed as a non-inferiority trial.

Conditions studied

Contrast Induced Nephropathy
Acute Myocardial Infarction

Keywords

contrast media
angiography
percutaneous coronary intervention

In context

Lead sponsor

Ospedale San Donato is the lead sponsor of 27 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Men or women aged ≥ 18
Patients with ST-elevation Myocardial Infarction presenting within 12 hours after the onset of symptoms (18 hours in case of cardiogenic shock), who are scheduled to undergo primary PCI
Patients who have signed and dated the written informed consent form

Exclusion criteria

Exclusion Criteria:

Patients in pregnancy or lactation
Long-term dialysis
Administration of any investigational drug within the previous 30 days
Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
Contraindications to the study drug or the cardiac catheterization procedure
Previous participation in this study
As the discretion of the investigator, the patient has any conditions not appropriate to the usage of iodinated contrast agent or not appropriate to undergo cardiac catheterization procedure

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 432 participants (estimated)

Study arms

Active comparator
iodixanol
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
Drug: Iodixanol
Active comparator
iopromide
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Drug: Iopromide

Interventions

DrugIodixanol
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
Also known as: Visipaque®
DrugIopromide
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Also known as: Ultravist®

What researchers measure

Primary outcomes

Incidence of Contrast Induced Nephropathy (CIN) between the two study groups, defined as relative increase of serum Creatinine of 25% or more from basal values
Time frame: days 1, 2, 3, and at discharge

Secondary outcomes

TIMI grade flow
Time frame: before and after primary PCI
Corrected TFC (TIMI frame count)
Time frame: after primary PCI
TMPG (TIMI Myocardial Perfusion Grade)
Time frame: after PCI
LFR slope (load to function slope)
Time frame: after primary PCI
MACE
Time frame: 1, 6, 12 months
absolute increase in serum Creatinine
Time frame: days 1, 2, 3, and at discharge
relative increase in serum creatinine of 50% or more
Time frame: days 1, 2, 3, and at discharge

Study locations

1 site

Cardiovascular Department, Ospedale S.Donato
Arezzo, AR 52100, Italy

References and documents

Publications

Bolognese L, Falsini G, Grotti S, Limbruno U, Liistro F, Carrera A, Angioli P, Picchi A, Ducci K, Pierli C. The contrast media and nephrotoxicity following coronary revascularization by primary angioplasty for acute myocardial infarction study: design and rationale of the CONTRAST-AMI study. J Cardiovasc Med (Hagerstown). 2010 Mar;11(3):199-206. doi: 10.2459/JCM.0b013e32833186a4. PubMed 19829124 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2008 and a primary completion of Apr 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 22, 2009
First posted: Jan 23, 2009
Start: Dec 2008
Primary completionActual: Apr 2010
Last update: Nov 16, 2010

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00827788
Lead sponsor: Ospedale San Donato
Collaborators: Ospedale Le Scotte, Ospedale della Misericordia - Grosseto
First posted: Jan 23, 2009
Start date: Dec 2008
Primary completion: Apr 2010
Last update: Nov 16, 2010

Study contacts

Leonardo Bolognese, MD, FESC

principal investigator · Ospedale SanDonato

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Iopromide

Other studies from this sponsor

Ospedale San Donato

Start the discussion