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

Phase 1

• Conditions: CT angiography of the coronary arteries; MedDRA version: 13.1Level: HLGTClassification code 10011082Term: Coronary artery disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001419-29-AT
• Lead Sponsor: niversitätsklinik für Radiodiagnostik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-13
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 460

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>•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<br>•To assess differences in patient discomfort after the administration of different contrast agents<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): •Assessment of discomfort<br>;Timepoint(s) of evaluation of this end point: After CT angiography