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Coronary Artery DiseaseNCT01625533

Safety and Efficacy Study of Dual-axis Rotational Versus Standard Coronary Angiography

An observational study of 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 purpose of this study is to assess the clinical safety and efficacy of dual-axis rotational coronary angiography (DARCA) in the diagnosis of coronary artery disease by directly comparing it to standard coronary angiography (SA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Standard Coronary Angiography and Dual-axis Rotational Coronary Angiography
Type of treatment
Surgery or procedure
How many people
576 participants
Where
1 siteChina
Study dates
Jun 2012to Jul 2013
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing diagnostic coronary angiography at the General Hospital of Chinese People's Armed Police Forces.

Who may be able to join

  • Age >18 years old
  • A clinical indication for diagnostic coronary angiography to evaluate possible CAD

Who cannot join

  • Pregnancy
  • Known allergy to iodinated contrast
  • Renal insufficiency (>1.5mg/dL)
  • Cardiogenic shock
  • Acute myocardial infarction within one week
  • Prior coronary artery bypass graft treatment
  • Prior percutaneous coronary intervention treatment

Trial locations and contacts

1 site in 1 country.

China1 site

  • Division of Cardiology, General Hospital of Chinese People's Armed Police Forces

    Beijing, Beijing Municipality, 100039

Other trials in China

About this study

Official title: Randomized Study on the Safety and Efficacy of Dual-axis Rotational Versus Standard Coronary Angiography

The purpose of this study is to assess the clinical safety and efficacy of dual-axis rotational coronary angiography (DARCA) in the diagnosis of coronary artery disease by directly comparing it to standard coronary angiography (SA).

Read the detailed description

Dual-axis rotational coronary angiography (DARCA) was developed as an innovative adaptation of rotational angiography (RA), but it requires a longer coronary injection compared to standard coronary angiography (SA). The risk of complications from the contrast agent (such as discomfort, warmth, pain, hypotension and bradycardia) is increased with the use of DARCA. It remains to be evaluated whether this approach is also suitable for coronary angiography, especially using in the patients with complex coronary lesions. Previous studies revealed promising results, but the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The purpose of this study is to evaluate the feasibility, safety, clinical tolerance, and hemodynamic effect of DARCA in comparison to the well-established SA.

Being tested
Standard Coronary Angiography, Dual-axis Rotational Coronary Angiography
Keywords
Coronary Angiography, Rotational Coronary Angiography, Contrast media, Radiation
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.

  • Standard Coronary AngiographyProcedure or surgery

    Also called Conventional Coronary Angiography

    Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.

  • Dual-axis Rotational Coronary AngiographyProcedure or surgery

    Also called DARA, XPERSWING

    Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.

Study groups in NCT01625533
Study groupRoleWhat they receive
SA groupPatients using SA for the diagnosis of coronary artery disease are assigned to the SA group.
Receives: Procedure: Standard Coronary Angiography
DARCA groupPatients using DARCA for the diagnosis of coronary artery disease are assigned to the DARCA group.
Receives: Procedure: Dual-axis Rotational Coronary Angiography

What is being measured

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

  1. Clinical safety of the patient during coronary angiography(CA)

    The patients were closely observed and questioned regarding discomfort and adverse events during or immediately after CA. The sensation of warmth or pain, including chest pain, is considered as discomfort. Adverse events include arrhythmias, hemodynamic compromise, chest pain described as angina-like pain and any untoward event which jeopardises the patient's life or prolongs the planned hospital stay. If patients experienced bradycardia, only bradycardia with a decrease in heart rate of 20% from the baseline was counted. Hemodynamic compromise was defined as a decrease in systolic blood pressure by > 20 mmHg to < 90 mmHg.

    Measured: At time of CA

Secondary outcomes (2)

  1. Patient safety determined by contrast and radiation dose

    The contrast usage (ml) and radiation exposure (mGycm2) are recorded from the point of selective catheter engagement in the coronary ostium to the completion of the diagnostic study. The contrast and radiation to perform isocentering are included during DARCA. The contrast and radiation required to engage the coronary ostia, exchange catheters, and perform non-coronary angiography are excluded from the analysis.

    Measured: At time of CA

  2. Clinical utility of dual-axis rotational coronary angiography(DARCA)

    The clinical utility of DARCA is determined by the number of additional acquisitions required beyond the protocol and the procedure time required for completing CA.The procedure time (sec.) is recorded from the point of selective catheter engagement in the coronary ostium to the completion of the diagnostic study. The time to perform isocentering is included during DARCA. The time required to engage the coronary ostia, exchange catheters, and perform non-coronary angiography is excluded from the analysis.

    Measured: At time of CA

Timeline

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

  1. First posted21 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

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
576 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01625533
Sponsor's protocol ID
20120601
Status last verified
Jun 2015
First submitted
13 Jun 2012
Last updated
8 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

  • Maddux JT, Wink O, Messenger JC, Groves BM, Liao R, Strzelczyk J, Chen SY, Carroll JD. Randomized study of the safety and clinical utility of rotational angiography versus standard angiography in the diagnosis of coronary artery disease. Catheter Cardiovasc Interv. 2004 Jun;62(2):167-74. doi: 10.1002/ccd.20036.

    PubMed 15170705

  • Empen K, Kuon E, Hummel A, Gebauer C, Dorr M, Konemann R, Hoffmann W, Staudt A, Weitmann K, Reffelmann T, Felix SB. Comparison of rotational with conventional coronary angiography. Am Heart J. 2010 Sep;160(3):552-63. doi: 10.1016/j.ahj.2010.06.011.

    PubMed 20826266

  • Gomez-Menchero AE, Diaz JF, Sanchez-Gonzalez C, Cardenal R, Sanghvi AB, Roa-Garrido J, Rodriguez-Lopez JL. Comparison of dual-axis rotational coronary angiography (XPERSWING) versus conventional technique in routine practice. Rev Esp Cardiol (Engl Ed). 2012 May;65(5):434-9. doi: 10.1016/j.recesp.2011.12.014. Epub 2012 Apr 1. English, Spanish.

    PubMed 22465608

  • Grech M, Debono J, Xuereb RG, Fenech A, Grech V. A comparison between dual axis rotational coronary angiography and conventional coronary angiography. Catheter Cardiovasc Interv. 2012 Oct 1;80(4):576-80. doi: 10.1002/ccd.23415. Epub 2012 Jan 12.

    PubMed 22105940

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of 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 7 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 8 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?

Clinical safety of the patient during coronary angiography(CA) (time frame: At time of CA). 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 NCT01625533, which also lists 7 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 8 Jun 2015.

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