Coronary Artery DiseaseNCT01083134
The Correlation of Heart Hemodynamic Status Between 320 Multidetector Computed Tomography, Echocardiography and Cardiac Catheterization in Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2010to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: According to Diamond and Forrester colleague, there are risks including age, gender, smoking, diabetes, and dyslipidemia for coronary artery disease.
Who may be able to join
- Intermediate or high risk for coronary artery disease
- Healthy volunteers
Who cannot join
- Unstable angina
- Acute myocardial infarction
- Active cancer status
- Renal failure(Creatinine > 1.5 mg/dl)
- Contrast allergy history
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cheng Gung Memorial Hospital at Linkou
Taipei
Tsang-Tang Hsieh, MD, +886 -3-3196200 ext. 3656, tth3388@adm.cgmh.org.tw
Cheng Hung Lee, MD
About this study
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.
- Conditions
- Coronary Artery Disease
- Keywords
- CAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| percentage of stenosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2015 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083134
- Sponsor's protocol ID
- 98-4077B
- Status last verified
- Jun 2011
- First submitted
- 7 Mar 2010
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16426789Hoffmann 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.
PubMed 17075011Johnson 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.
PubMed 17179348Scheffel 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.
PubMed 17031451Einstein 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.
PubMed 19011135Hausleiter 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.
PubMed 16520411Yates 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.
PubMed 15151967Hein 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.
PubMed 19137311Expert 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.
PubMed 11368702Diamond 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.
PubMed 440357
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Heart Hemodynamic Status Between 320 Multidetector Computed Tomography, Echocardiography and Cardiac Catheterization in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01083134
- Acronym / sponsor ID
- 98-4077B
- Conditions
- Coronary Artery Disease
- Keywords
- CAD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| percentage of stenosis | – | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- According to Diamond and Forrester colleague, there are risks including age, gender, smoking, diabetes, and dyslipidemia for coronary artery disease.
Key inclusion criteria (2 listed)
- Intermediate or high risk for coronary artery disease
- Healthy volunteers
Key exclusion criteria (6 listed)
- Unstable angina
- Acute myocardial infarction
- Active cancer status
- Renal failure(Creatinine > 1.5 mg/dl)
- Contrast allergy history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Background: PubMed 16426789Achenbach 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.
- Background: PubMed 17075011Hoffmann 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.
- Background: PubMed 17179348Johnson 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.
- Background: PubMed 17031451Scheffel 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.
- Background: PubMed 19011135Einstein 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.
- Background: PubMed 16520411Hausleiter 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.
- Background: PubMed 15151967Yates 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.
- Background: PubMed 19137311Hein 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.
- Background: PubMed 11368702Expert 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.
- Background: PubMed 440357Diamond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng Gung Memorial Hospital at Linkou
Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01083134, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.