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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00612092
First received: January 28, 2008
Last updated: August 26, 2008
Last verified: August 2008
  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

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612092

Contacts
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

Locations
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         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
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 July 20, 2014