NCT00612092

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 27, 2008

Status Verified

August 1, 2008

Enrollment Period

8 months

First QC Date

January 28, 2008

Last Update Submit

August 26, 2008

Conditions

Coronary Disease

Keywords

Coronary CT angiographyRadiation dose estimates

Outcome Measures

Primary Outcomes (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.

    1 month

Secondary Outcomes (3)

  • 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

    30 days

  • 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

    30 days

  • frequency of non-diagnostic CTA studies when comparing studies scanned with the helical vs. the sequential scan protocol

    30 days

Study Arms (2)

1

EXPERIMENTAL

Standard spiral CT protocol

Radiation: Spiral image acquisition

2

ACTIVE COMPARATOR

Sequential CT protocol

Radiation: sequential image acquisition

Interventions

Spiral image acquisitionRADIATION

standard spiral scan protocol

1
sequential image acquisitionRADIATION

sequential CT scan protocol

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

RECRUITING

Related Publications (1)

  • Hausleiter J, Meyer TS, Martuscelli E, Spagnolo P, Yamamoto H, Carrascosa P, Anger T, Lehmkuhl L, Alkadhi H, Martinoff S, Hadamitzky M, Hein F, Bischoff B, Kuse M, Schomig A, Achenbach S. Image quality and radiation exposure with prospectively ECG-triggered axial scanning for coronary CT angiography: the multicenter, multivendor, randomized PROTECTION-III study. JACC Cardiovasc Imaging. 2012 May;5(5):484-93. doi: 10.1016/j.jcmg.2011.12.017.

    PMID: 22595156DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Joerg Hausleiter, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joerg Hausleiter, MD

CONTACT

+49 89 1218hausleiter@dhm.mhn.de

Tanja Meyer, MD

CONTACT

+49 89 1218meyert@dhm.mhn.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 11, 2008

Study Start

May 1, 2008

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

August 27, 2008

Record last verified: 2008-08

Locations

DE(1)