Coronary Artery DiseaseNCT01776866

Image Content Analysis of Dural-axis Rotational Versus Standard Coronary Angiography

A study testing Coronary Angiography in people with Coronary Artery Disease, run by General Hospital of Chinese Armed Police Forces at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators hypothesized that dual-axis rotational coronary angiography was non-inferior to standard coronary angiography with respect to diagnosis of coronary artery disease. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Coronary Artery Disease
What is being tested?: Coronary Angiography
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteChina
Study dates: Jan 2013to May 2013
Phase: Interventional
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age>18 years old, <80 years old
a clinical indication for diagnostic coronary angiography to evaluate possible coronary artery disease

Who cannot join

Pregnancy
Known allergy to iodinated contrast
Patients who had received iodinated contrast material within the last week or were unable to give consent
Renal insufficiency (>1.5mg/dL)
Acute myocardial infarction within one week
Cardiogenic shock

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heart function worse than New York Heart Association functional class III
Left main coronary artery disease
Prior coronary artery bypass graft treatment
Prior percutaneous coronary intervention treatment

Trial locations and contacts

1 site in 1 country.

China1 site

General hospital of Chinese people's armed police forces
Beijing, 100039

Other trials in China

About this study

Official title: Comparison of Image Content Assessment Between Dural-axis Rotational and Standard Coronary Angiography

The investigators hypothesized that dual-axis rotational coronary angiography was non-inferior to standard coronary angiography with respect to diagnosis of coronary artery disease.

Read the detailed description

The prior studies have demonstrated that dual-axis rotational coronary angiography (DARCA) is associated with lower contrast usage and radiation exposure compared with standard coronary angiography (SA). Single-axis rotational coronary angiography (RA) has been proved by previous studies without any reduction in diagnostic accuracy compared to SA. However, the rotational protocol is obvious different between DARCA and single-axis RA. A recent study has assessed the diagnostic accuracy of DARCA, but this study was not designed for image content analysis and the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The diagnostic accuracy of DARCA aroused our attention.

Conditions: Coronary Artery Disease
Being tested: Coronary Angiography
Keywords: Coronary Angiography, Rotational Coronary Angiography, Contrast Media, Radiation, Quantitative Coronary Angiography
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.

Coronary AngiographyProcedure or surgery
Coronary angiography include standard coronary angiography (SA) and dual-axis rotational coronary angiography (DARCA). Patient first undergo SA of either left or right coronary system followed by DARCA.

Study groups in NCT01776866
Study group	Role	What they receive
Coronary Angiography	Other	Patient first undergo standard coronary angiography(SA) of either left or right coronary system followed by dual-axis rotational coronary angiography(DARCA). The SA protocol consist of six different projections (right anterior oblique (RAO)-caudal, RAO-cranial (CRA), left anterior oblique (LAO)-CRA, LAO-caudal (CAU), antero-posterior (AP)-CRA and AP-CAU) for left coronary artery (LCA) and two projections (LAO and AP-cranial) for right coronary artery (RCA). The DARCA protocol consist of two coronary acquisitions specified by the protocol: one for LCA (Swing LCA CRA 35 5.8s), another for RCA (Swing RCA AP 4.0s). Receives: Procedure: Coronary Angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnosis of Coronary Heart Disease
The number of patients diagnosed as coronary heart disease by either angiographic modality by two blinded independent reviewers are recorded. The single criterion for diagnosis of coronary heart disease is the presence of coronary artery stenoses greater than or equal to 50%.
Measured: After coronary angiography, an expected average of 1 month

Secondary outcomes (3)

Coronary Lesion Assessment
The number of lesions greater than or equal to 50% detected by either angiographic modality by two blinded independent reviewers are recorded. In addition, they are asked to comment on the characteristics of the greater than or equal to 50% lesions (number of coronary lesions, number of bifurcation lesions, location of lesion, multivessel disease, American College of Cardiology (ACC) lesion classification and Medina classification for bifurcation lesions)
Measured: After coronary angiography, an expected average of 1 month
Quantitative Coronary Angiography
The quantitative coronary angiography analysis of the more than or equal to 50% lesions detected by the lesion assessment of either reviewer one or reviewer two in both angiographic modalities (lesion length, minimum lumen diameter, diameter stenosis). Quantitative coronary angiography analysis will be performed by the third different blinded, independent, reviewer.
Measured: After coronary angiography, an expected average of 1 month
Diagnostic Screening Adequacy
Two different experienced reviewers analyzed the angiographic sets based on a Likert Scale for each vessel segment, calcification, thrombolysis in myocardial infarction (TIMI) flow, collaterals, displaying the lesions and bifurcations.
Measured: After coronary angiography, an expected average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013May 2013

First posted28 Jan 2013 (estimated)
Study startJan 2013
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01776866
Sponsor's protocol ID: 20130101
Other IDs: 20130101
Status last verified: Jun 2015
First submitted: 16 Jan 2013
Last updated: 30 Jun 2015
Results posted: No
Data monitoring committee: Yes

Publications

Garcia JA, Agostoni P, Green NE, Maddux JT, Chen SY, Messenger JC, Casserly IP, Hansgen A, Wink O, Movassaghi B, Groves BM, Van Den Heuvel P, Verheye S, Van Langenhove G, Vermeersch P, Van den Branden F, Yeghiazarians Y, Michaels AD, Carroll JD. Rotational vs. standard coronary angiography: an image content analysis. Catheter Cardiovasc Interv. 2009 May 1;73(6):753-61. doi: 10.1002/ccd.21918.
PubMed 19180661
Klein AJ, Garcia JA, Hudson PA, Kim MS, Messenger JC, Casserly IP, Wink O, Hattler B, Tsai TT, Chen SY, Hansgen A, Carroll JD. Safety and efficacy of dual-axis rotational coronary angiography vs. standard coronary angiography. Catheter Cardiovasc Interv. 2011 May 1;77(6):820-7. doi: 10.1002/ccd.22804. Epub 2011 Mar 11.
PubMed 20853352
Liu HL, Jin ZG, Yang SL, Luo JP, Ma DX, Liu Y, Han W. Randomized study on the safety and efficacy of dual-axis rotational versus standard coronary angiography in. Chin Med J (Engl). 2012 Mar;125(6):1016-22.
PubMed 22613524
Jin ZG, Bai R, Li Y, Yang Y, Han W, Zhao Q, Zhang L, Liu HL. Comparison of diagnostic accuracy of dual-axis rotational versus standard coronary angiography. Int J Cardiovasc Imaging. 2020 Feb;36(2):187-195. doi: 10.1007/s10554-019-01711-9. Epub 2019 Oct 18.
PubMed 31628576

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Image Content Assessment Between Dural-axis Rotational and Standard Coronary Angiography
ClinicalTrials.gov ID: NCT01776866
Acronym / sponsor ID: 20130101
Conditions: Coronary Artery Disease
Keywords: Coronary Angiography, Rotational Coronary Angiography, Contrast Media, Radiation, Quantitative Coronary Angiography
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
Study start: Jan 2013
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 28 Jan 2013 (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.

The investigators hypothesized that dual-axis rotational coronary angiography was non-inferior to standard coronary angiography with respect to diagnosis of coronary artery disease.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Coronary Angiography	Other	Procedure: Coronary AngiographyPatient first undergo standard coronary angiography(SA) of either left or right coronary system followed by dual-axis rotational coronary angiography(DARCA). The SA protocol consist of six different projections (right anterior oblique (RAO)-caudal, RAO-cranial (CRA), left anterior oblique (LAO)-CRA, LAO-caudal (CAU), antero-posterior (AP)-CRA and AP-CAU) for left coronary artery (LCA) and two projections (LAO and AP-cranial) for right coronary artery (RCA). The DARCA protocol consist of two coronary acquisitions specified by the protocol: one for LCA (Swing LCA CRA 35 5.8s), another for RCA (Swing RCA AP 4.0s).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age>18 years old, <80 years old
a clinical indication for diagnostic coronary angiography to evaluate possible coronary artery disease

Key exclusion criteria (10 listed)

Pregnancy
Known allergy to iodinated contrast
Patients who had received iodinated contrast material within the last week or were unable to give consent
Renal insufficiency (>1.5mg/dL)
Acute myocardial infarction within one week

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Coronary AngiographyCoronary angiography include standard coronary angiography (SA) and dual-axis rotational coronary angiography (DARCA). Patient first undergo SA of either left or right coronary system followed by DARCA.	Procedure or surgery	Coronary Angiography

Primary outcome

Diagnosis of Coronary Heart Disease
Time frame: After coronary angiography, an expected average of 1 month
The number of patients diagnosed as coronary heart disease by either angiographic modality by two blinded independent reviewers are recorded. The single criterion for diagnosis of coronary heart disease is the presence of coronary artery stenoses greater than or equal to 50%.

3 secondary outcomes

Coronary Lesion Assessment
Time frame: After coronary angiography, an expected average of 1 month
Quantitative Coronary Angiography
Time frame: After coronary angiography, an expected average of 1 month
Diagnostic Screening Adequacy
Time frame: After coronary angiography, an expected average of 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
Background: PubMed 19180661Garcia JA, Agostoni P, Green NE, Maddux JT, Chen SY, Messenger JC, Casserly IP, Hansgen A, Wink O, Movassaghi B, Groves BM, Van Den Heuvel P, Verheye S, Van Langenhove G, Vermeersch P, Van den Branden F, Yeghiazarians Y, Michaels AD, Carroll JD. Rotational vs. standard coronary angiography: an image content analysis. Catheter Cardiovasc Interv. 2009 May 1;73(6):753-61. doi: 10.1002/ccd.21918.
Background: PubMed 20853352Klein AJ, Garcia JA, Hudson PA, Kim MS, Messenger JC, Casserly IP, Wink O, Hattler B, Tsai TT, Chen SY, Hansgen A, Carroll JD. Safety and efficacy of dual-axis rotational coronary angiography vs. standard coronary angiography. Catheter Cardiovasc Interv. 2011 May 1;77(6):820-7. doi: 10.1002/ccd.22804. Epub 2011 Mar 11.
Background: PubMed 22613524Liu HL, Jin ZG, Yang SL, Luo JP, Ma DX, Liu Y, Han W. Randomized study on the safety and efficacy of dual-axis rotational versus standard coronary angiography in. Chin Med J (Engl). 2012 Mar;125(6):1016-22.
Derived from this study: PubMed 31628576Jin ZG, Bai R, Li Y, Yang Y, Han W, Zhao Q, Zhang L, Liu HL. Comparison of diagnostic accuracy of dual-axis rotational versus standard coronary angiography. Int J Cardiovasc Imaging. 2020 Feb;36(2):187-195. doi: 10.1007/s10554-019-01711-9. Epub 2019 Oct 18.

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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.

Liu Huiliang, M.D. study chair

General hospital of Chinese people's armed police forces

Jin Zhigeng, M.M. study director

General hospital of Chinese people's armed police forces

Yang Shengli, M.D. principal investigator

General hospital of Chinese people's armed police forces

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Angiography in people with Coronary Artery Disease, run by General Hospital of Chinese Armed Police Forces at 1 site in China.

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 10 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: finished, as of the sponsor's last update on 30 Jun 2015. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnosis of Coronary Heart Disease (time frame: After coronary angiography, an expected average of 1 month). 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 NCT01776866, which also lists 4 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 30 Jun 2015.