Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A Sequential Scan Protocol (PROTECTION-III)
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Coronary Disease |
Radiation: Spiral image acquisition Radiation: sequential image acquisition |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- frequency of non-diagnostic CTA studies when comparing studies scanned with the helical vs. the sequential scan protocol [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Joerg Hausleiter, MD | +49 89 1218 ext 1585 | hausleiter@dhm.mhn.de |
| Contact: Tanja Meyer, MD | +49 89 1218 ext 4500 | meyert@dhm.mhn.de |
| Germany | |
| Deutsches Herzzentrum Muenchen | Recruiting |
| Munich, Germany, 80636 | |
| Contact: Joerg Hausleiter, MD +49 89 1218 ext 1585 hausleiter@dhm.mhn.de | |
| Principal Investigator: Joerg Hausleiter, MD | |
| Principal Investigator: | Joerg Hausleiter, MD | Deutsches Herzzentrum Muenchen |
More Information
No publications provided by Deutsches Herzzentrum Muenchen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | PD Dr. Joerg Hausleiter, Deutsches Herzzentrum |
| ClinicalTrials.gov Identifier: | NCT00612092 History of Changes |
| Other Study ID Numbers: | GE IDE No. R00308 |
| Study First Received: | January 28, 2008 |
| Last Updated: | August 26, 2008 |
| Health Authority: | Germany: Ethics Commission |
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 Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 22, 2013