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Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A Sequential Scan Protocol (PROTECTION-III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00612092
Recruitment Status : Unknown
Verified August 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
First Posted : February 11, 2008
Last Update Posted : August 27, 2008
Information provided by:
Deutsches Herzzentrum Muenchen

Brief Summary:

The objective of this study is to compare radiation dose of a standard spiral scan with the a new sequential scan protocol. We hypothesize that the sequential 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 spiral versus sequential studies compared to invasive angiography in patients who underwent subsequent invasive coronary angiography.

Condition or disease Intervention/treatment Phase
Coronary Disease Radiation: Spiral image acquisition Radiation: sequential image acquisition Phase 4

Detailed Description:

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 <75 bpm for dual source CT and <65 bpm for 64-slice CT). 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 standard spiral protocol or with the sequential 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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A Sequential Scan Protocol
Study Start Date : May 2008
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Standard spiral CT protocol
Radiation: Spiral image acquisition
standard spiral scan protocol
Active Comparator: 2
Sequential CT protocol
Radiation: sequential image acquisition
sequential CT scan protocol

Primary Outcome Measures :
  1. Compared with a helical scan protocol the use of a sequential scan protocol is associated with a comparable diagnostic image quality, while the radiation dose estimates are significantly reduced. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. impact of the sequential scan protocol on quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios [ Time Frame: 30 days ]
  2. diagnostic accuracy (sensitivity, specificity as well as positive and negative predictive values) for studies scanned with helical vs. sequential scan protocol when compared with invasive coronary angiography on a per-vessel based analysis [ Time Frame: 30 days ]
  3. frequency of non-diagnostic CTA studies when comparing studies scanned with the helical vs. the sequential scan protocol [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
  • stable sinus rhythm
  • heart rate < 75 bpm with dual-source CT or < 65 bpm with single-source CT
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00612092

Contact: Joerg Hausleiter, MD +49 89 1218 ext 1585
Contact: Tanja Meyer, MD +49 89 1218 ext 4500

Deutsches Herzzentrum Muenchen Recruiting
Munich, Germany, 80636
Contact: Joerg Hausleiter, MD    +49 89 1218 ext 1585   
Principal Investigator: Joerg Hausleiter, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Principal Investigator: Joerg Hausleiter, MD Deutsches Herzzentrum Muenchen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: PD Dr. Joerg Hausleiter, Deutsches Herzzentrum Identifier: NCT00612092     History of Changes
Other Study ID Numbers: GE IDE No. R00308
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: August 27, 2008
Last Verified: August 2008

Keywords provided by Deutsches Herzzentrum Muenchen:
Coronary CT angiography
Radiation dose estimates

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases