NCT02462044

Brief Summary

Computed tomographic angiography (CTA) is an important prognostic tool with regard to the detection of coronary artery stenoses. Both iodine delivery rate (IDR; the amount of iodine delivered to the patient per second) and iodine concentration are decisive factors in the opacification of arterial vessels. There remains to be some debate in the literature about whether the use of high iodine concentration contrast media is beneficial compared to lower iodine concentrations. To date, there have not been any studies comparing intracoronary attenuation using concentrated contrast media lower than 300 mg I/ml at coronary CTA. For a reliable comparison of CM with different iodine concentrations, adapted injection protocols insuring an identical IDR (in g iodine per second) are mandatory. The investigators hypothesize that usage of lower iodine concentrations, while maintaining identical IDR and total iodine load, will result in comparable diagnostical intra-vascular attenuation in CTA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

September 9, 2014

Last Update Submit

January 4, 2016

Conditions

Coronary Artery DiseaseCoronary Stenosis

Keywords

Computed tomographyCoronary CTAContrast media

Outcome Measures

Primary Outcomes (1)

  • intravascular contrast enhancement

    intravascular contrast enhancement and image quality based on different contrast media (240, 300, 370) as measured by circular ROI in the target vessels using dedicated post processing.

    two years

Secondary Outcomes (3)

  • time to peak

    two years

  • bolus homogeneity

    two years

  • patient comfort

    two years

Study Arms (3)

240

EXPERIMENTAL

Group 240 will receive CM with 240 mg Iodine/ml IDR 2.0 gI/s

Drug: 240 mg Iodine

300

EXPERIMENTAL

Group 300 will receive CM with 300 mg Iodine/ml IDR 2.0 gI/s

Drug: 300 mg Iodine

370

EXPERIMENTAL

Group 370 will receive CM with 370 mg Iodine/ml IDR 2.0 gI/s

Drug: 370 mg Iodine

Interventions

240 mg IodineDRUG
Also known as: 240 mg Iodine/ml IDR 2.0 gI/s
240
300 mg IodineDRUG
Also known as: 300 mg Iodine/ml IDR 2.0 gI/s
300
370 mg IodineDRUG
Also known as: 240 mg Iodine/ml IDR 2.0 gI/s
370

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atypical or typical chest pain

You may not qualify if:

  • Unstable angina
  • Hemodynamic instability
  • History of CAD
  • Pregnancy
  • Renal insufficiency (defined as glomerular filtration rate (GFR) \<45ml/min or \<60ml +diabetes
  • HR \> 90 bpm and the inability to receive beta-blockers and iodine allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6202AZ, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Stenosis

Interventions

Iodine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

HalogensElementsInorganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marco Das, MD, PhD

Study Record Dates

First Submitted

September 9, 2014

First Posted

June 3, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

NL(1)