NCT01060657

Brief Summary

To evaluate the clinical values of using dose reduction techniques in 64-row multi-slice CT coronary artery imaging.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

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

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

1.4 years

First QC Date

January 31, 2010

Last Update Submit

February 1, 2010

Conditions

Coronary Artery Disease

Keywords

X-ray Computed TomographyCoronary vesselsRadiation dosage

Study Arms (2)

conventional (C) group

low dose (L) groups

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Five hundred patients will be recruited over one and half years from our institution and other hospitals for suspected coronary artery disease. All patients will give informed consent and our Institutional Review Board approved the study.

You may qualify if:

  • body height and weight of 160 cm to 175 cm, and 55 kg to 75 kg, respectively.

You may not qualify if:

  • with acute heart failure, severe arrhythmia and severe renal dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NO.69 Road yongding

Beijing, Haidian, 100039, China

Location

Related Publications (1)

  • Bischoff B, Hein F, Meyer T, Hadamitzky M, Martinoff S, Schomig A, Hausleiter J. Impact of a reduced tube voltage on CT angiography and radiation dose: results of the PROTECTION I study. JACC Cardiovasc Imaging. 2009 Aug;2(8):940-6. doi: 10.1016/j.jcmg.2009.02.015.

    PMID: 19679281BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2010

First Posted

February 2, 2010

Study Start

December 1, 2009

Primary Completion

May 1, 2011

Study Completion

December 1, 2011

Last Updated

February 2, 2010

Record last verified: 2010-01

Locations

CN(1)