Bestimmung des Einflusses von iodhältigen Kontrastmitteln auf die Veränderungen der Herzrate und die diagnostische Bildqualität während der CT Angiographie der Koronararterien

Influence of iodinated contrast agents on heart rate variation and diagnostic image quality during CT angiography of the coronary arteries

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001419-29-AT

Enrollment

460

Registered

2011-04-13

Start date

2011-05-05

Completion date

Unknown

Last updated

2020-07-20

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

Conditions

CT angiography of the coronary arteries MedDRA version: 13.1 Level: HLGT Classification code 10011082 Term: Coronary artery disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: VISIPAQUE 320 mg J/ml - parenterale Röntgenkontrastmittellösung Product Name: VISIPAQUE 320 mg J/ml - parenterale Röntgenkontrastmittellösung Pharmaceutical Form: Solution for injection IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • patients’ age at least 18 years • sinus rhythm • no history of bypass graft surgery or heart transplantation • patients referred to rule out/diagnose CAD Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 230 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 230

Exclusion criteria

Exclusion criteria: • patients below 18 years • pregnant or breast feeding women • no sinus rhythm • untreated hyperthyreosis • previous anaphylactic reaction to iodinated contrast agents • impaired renal function (eGFR below 60 ml/min/1,73m2) • history of plasmocytoma / multiple myeloma • reatment with metformin-containing drugs • history of coronary bypass graft surgery • heart transplant recipients • CI to beta-blockers: asthma, COPD, etc.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To demonstrate the possibility of reducing the heart rate changes during CT angiography of the coronary arteries by selecting an iso-osmolar contrast agent;Secondary Objective: • To show the importance of heart rate changes for diagnostic image quality in terms of assessable segments during CT angiography of the coronary arteries. • To demonstrate non-inferiority of Visipaque 320 as compared to iomeprol 400 with regard to image quality in terms of arterial enhancement when using the same iodine application rate • To assess differences in patient discomfort after the administration of different contrast agents ;Primary end point(s): • Changes of heart rate during CT angiography oft he coronary arteries;Timepoint(s) of evaluation of this end point: During and after CT angiography	—

Measure

Time frame

Main Objective: • To demonstrate the possibility of reducing the heart rate changes during CT angiography of the coronary arteries by selecting an iso-osmolar contrast agent;Secondary Objective: • To show the importance of heart rate changes for diagnostic image quality in terms of assessable segments during CT angiography of the coronary arteries. • To demonstrate non-inferiority of Visipaque 320 as compared to iomeprol 400 with regard to image quality in terms of arterial enhancement when using the same iodine application rate • To assess differences in patient discomfort after the administration of different contrast agents ;Primary end point(s): • Changes of heart rate during CT angiography oft he coronary arteries;Timepoint(s) of evaluation of this end point: During and after CT angiography

—

Secondary

Measure	Time frame
Secondary end point(s): • Assessment of discomfort ;Timepoint(s) of evaluation of this end point: After CT angiography	—

Countries

Austria

Contacts

Public ContactAbteilung für Kardiovaskuläre und I

Universitätsklinik für Radiodiagnostik

christian.loewe@meduniwien.ac.at+431404005802

Outcome results

None listed

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