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Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A 100kV Protocol

NCT ID: NCT00611780

Last Updated: 2008-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-01-31

Brief Summary

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The objective of this study is to compare radiation dose of a 100kV scan protocol to the standard 120kV scan protocol. We hypothesize that the 100kV scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior.

Secondary endpoints of the study include quantitative image quality parameters, diagnostic accuracy for 120 vs.100kV studies compared to invasive angiography in patients who underwent subsequent invasive coronary angiography

Detailed Description

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All patients scheduled for a coronary CT scan are screened for inclusion and exclusion criteria. Patients are included if they have stable sinus rhythm (heart rate \<100 bpm) and a body weight \< 90 kg or a body mass index (BMI) \< 30. Informed signed consent is obtained from these patients and the CT scan is prepared. After topogram scan and the native scan for Ca-Scoring, patients are randomized in two groups with the use of sealed envelopes. After that contrast-enhanced coronary CT angiography is performed with the 120kV- or 100kV-protocol.

The CT examination is evaluated by two experienced investigators on a per-vessel basis and all results and study-related data are collected in a dedicated database. For assessment of image quality, a previously established 4-point score system is used and quantitative image quality parameters are measured.

A 30 day follow-up after the CT examination aims to evaluate if patients underwent invasive coronary angiography or were scheduled for a myocardial stress / perfusion test (such as stress-echocardiography, myocardial scintigraphy or stress perfusion imaging by MRI).

Conditions

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Coronary Disease

Keywords

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Coronary CT angiography Radiation dose estimates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Reduced tube voltage of 100kV.

Group Type EXPERIMENTAL

tube voltage

Intervention Type RADIATION

reduced voltage of 100 kV

2

Standard tube voltage of 120kV.

Group Type ACTIVE_COMPARATOR

tube voltage

Intervention Type RADIATION

standard 120 kV

Interventions

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tube voltage

standard 120 kV

Intervention Type RADIATION

tube voltage

reduced voltage of 100 kV

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
* stable sinus rhythm
* patient weight \< 90kg or body mass index \< 30 kg/m2
* signed informed consent

Exclusion Criteria

* non-ECG triggered studies
* non-coronary CTA studies, e.g. bypass graft CTAs, pre- or post EP studies, CABG planning studies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Deutsches Herzzentrum

Principal Investigators

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Joerg Hausleiter, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

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Deutsches Herzzentrum Muenchen

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Joerg Hausleiter, MD

Role: CONTACT

Phone: +49 89 1218

Email: [email protected]

Tanja Meyer, MD

Role: CONTACT

Phone: +49 89 1218

Email: [email protected]

Facility Contacts

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Joerg Hausleiter, MD

Role: primary

References

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Hausleiter J, Martinoff S, Hadamitzky M, Martuscelli E, Pschierer I, Feuchtner GM, Catalan-Sanz P, Czermak B, Meyer TS, Hein F, Bischoff B, Kuse M, Schomig A, Achenbach S. Image quality and radiation exposure with a low tube voltage protocol for coronary CT angiography results of the PROTECTION II Trial. JACC Cardiovasc Imaging. 2010 Nov;3(11):1113-23. doi: 10.1016/j.jcmg.2010.08.016.

Reference Type DERIVED
PMID: 21070998 (View on PubMed)

Other Identifiers

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GE IDE No. R00207

Identifier Type: -

Identifier Source: org_study_id