NCT01083134

Brief Summary

With the advances in multidetector computed tomography (MDCT) technology, CT angiography (CTA) of the coronary arteries using 64-slice or dual-source CT systems has evolved into a robust, alternative, noninvasive imaging technique to rule out coronary artery disease (CAD). Reported sensitivities and specificities of coronary CTA can compete with those of catheter angiography. Because CT is the major source of ionizing radiation in medicine, dual isotope myocardial perfusion scintigraphy and coronary CTA 16-, 64-slice MDCT and DSCT scanners are associated with the highest amount of radiation dose. Recently, a new generation of MDCT machines with even more detector row (320) has become clinically available. The maximum detector width of 16 cm enables the entire heart to be examined in a single rotation and within a single heartbeat and is expected to substantially reduce artifacts from breathing and body motion. Due to high volume coverage, 320-slice CT machines are able to perform a nonspiral, ECG-gated examination of the heart within a single breath-hold. The purpose of this study was to investigate the correlation of hemodynamic status of 320 MDCT, echocardiography, and coronary catheterization in patients who suspected coronary artery disease.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

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

March 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 29, 2014

Status Verified

June 1, 2011

Enrollment Period

5 years

First QC Date

March 7, 2010

Last Update Submit

July 28, 2014

Conditions

Keywords

CAD

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    one year

Study Arms (1)

percentage of stenosis

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

According to Diamond and Forrester colleague, there are risks including age, gender, smoking, diabetes, and dyslipidemia for coronary artery disease.

You may qualify if:

  • Intermediate or high risk for coronary artery disease
  • Healthy volunteers

You may not qualify if:

  • Unstable angina
  • Acute myocardial infarction
  • Active cancer status
  • Renal failure(Creatinine \> 1.5 mg/dl)
  • Contrast allergy history
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheng Gung Memorial Hospital at Linkou

Taipei, Taiwan

RECRUITING

Related Publications (10)

  • Achenbach S, Ropers D, Kuettner A, Flohr T, Ohnesorge B, Bruder H, Theessen H, Karakaya M, Daniel WG, Bautz W, Kalender WA, Anders K. Contrast-enhanced coronary artery visualization by dual-source computed tomography--initial experience. Eur J Radiol. 2006 Mar;57(3):331-5. doi: 10.1016/j.ejrad.2005.12.017. Epub 2006 Jan 19.

    PMID: 16426789BACKGROUND
  • Hoffmann U, Nagurney JT, Moselewski F, Pena A, Ferencik M, Chae CU, Cury RC, Butler J, Abbara S, Brown DF, Manini A, Nichols JH, Achenbach S, Brady TJ. Coronary multidetector computed tomography in the assessment of patients with acute chest pain. Circulation. 2006 Nov 21;114(21):2251-60. doi: 10.1161/CIRCULATIONAHA.106.634808. Epub 2006 Oct 30.

    PMID: 17075011BACKGROUND
  • Johnson TR, Nikolaou K, Wintersperger BJ, Knez A, Boekstegers P, Reiser MF, Becker CR. ECG-gated 64-MDCT angiography in the differential diagnosis of acute chest pain. AJR Am J Roentgenol. 2007 Jan;188(1):76-82. doi: 10.2214/AJR.05.1153.

    PMID: 17179348BACKGROUND
  • Scheffel H, Alkadhi H, Plass A, Vachenauer R, Desbiolles L, Gaemperli O, Schepis T, Frauenfelder T, Schertler T, Husmann L, Grunenfelder J, Genoni M, Kaufmann PA, Marincek B, Leschka S. Accuracy of dual-source CT coronary angiography: First experience in a high pre-test probability population without heart rate control. Eur Radiol. 2006 Dec;16(12):2739-47. doi: 10.1007/s00330-006-0474-0. Epub 2006 Sep 19.

    PMID: 17031451BACKGROUND
  • Einstein AJ. Radiation risk from coronary artery disease imaging: how do different diagnostic tests compare? Heart. 2008 Dec;94(12):1519-21. doi: 10.1136/hrt.2007.135731. No abstract available.

    PMID: 19011135BACKGROUND
  • Hausleiter J, Meyer T, Hadamitzky M, Huber E, Zankl M, Martinoff S, Kastrati A, Schomig A. Radiation dose estimates from cardiac multislice computed tomography in daily practice: impact of different scanning protocols on effective dose estimates. Circulation. 2006 Mar 14;113(10):1305-10. doi: 10.1161/CIRCULATIONAHA.105.602490. Epub 2006 Mar 6.

    PMID: 16520411BACKGROUND
  • Yates SJ, Pike LC, Goldstone KE. Effect of multislice scanners on patient dose from routine CT examinations in East Anglia. Br J Radiol. 2004 Jun;77(918):472-8. doi: 10.1259/bjr/21927258.

    PMID: 15151967BACKGROUND
  • Hein PA, Romano VC, Lembcke A, May J, Rogalla P. Initial experience with a chest pain protocol using 320-slice volume MDCT. Eur Radiol. 2009 May;19(5):1148-55. doi: 10.1007/s00330-008-1255-8. Epub 2009 Jan 10.

    PMID: 19137311BACKGROUND
  • Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.

    PMID: 11368702BACKGROUND
  • Diamond GA, Forrester JS. Analysis of probability as an aid in the clinical diagnosis of coronary-artery disease. N Engl J Med. 1979 Jun 14;300(24):1350-8. doi: 10.1056/NEJM197906143002402.

    PMID: 440357BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2010

First Posted

March 9, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2020

Last Updated

July 29, 2014

Record last verified: 2011-06

Locations