Dual Source CT Angiography for Detection of Coronary Artery Stenoses

Multicenter Evaluation of Coronary Dual Source CT Angiography in Patients With Intermediate Risk of Coronary Artery Stenoses

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01190579

Acronym

MEDIC

Enrollment

398

Registered

2010-08-27

Start date

2009-08-31

Completion date

2010-12-31

Last updated

2010-08-27

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

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease, Chest Pain, Computed Tomography

Brief summary

The trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

* suspected coronary artery disease * chest Pain * intermediate likelihood of coronary stenoses * planned invasive coronary angiography * age 30 to 80 years

Exclusion criteria

* non sinus rhythm * contrast allergy * renal failure * unstable clinical condition * previous coronary revascularization * calcium score exceeding 800 * inability to perform 10 second breathhold * possible pregnancy * metformin medication that cannot be interrupted * inability to establish antecubital iv access

Design outcomes

Primary

Measure	Time frame	Description
Accuracy for the detection of coronary artery stenoses	72 hours	Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results.

Secondary

Measure	Time frame	Description
Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography	1 hour	Patients will be monitored for one hour after injection of Ultravist 370 and Ultravist 300 intravenously to assess safety and detect side effects.

Countries

Denmark, Germany, India, Mexico, Singapore

Contacts

Primary ContactStephan Achenbach, MD

stephan.achenbach@uk-erlangen.de++49 9131 8535000

Backup ContactDieter Ropers, MD

dieter.ropers@uk-erlangen.de++49 9131 8535301

Outcome results