NCT01625533

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

June 13, 2012

Last Update Submit

June 3, 2015

Conditions

Coronary Artery Disease

Keywords

Coronary AngiographyRotational Coronary AngiographyContrast mediaRadiation

Outcome Measures

Primary Outcomes (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.

    At time of CA

Secondary Outcomes (2)

  • Patient safety determined by contrast and radiation dose

    At time of CA

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

    At time of CA

Study Arms (2)

SA group

Patients using SA for the diagnosis of coronary artery disease are assigned to the SA group.

Procedure: Standard Coronary Angiography

DARCA group

Patients using DARCA for the diagnosis of coronary artery disease are assigned to the DARCA group.

Procedure: Dual-axis Rotational Coronary Angiography

Interventions

Standard Coronary AngiographyPROCEDURE

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

Also known as: Conventional Coronary Angiography
SA group
Dual-axis Rotational Coronary AngiographyPROCEDURE

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

Also known as: DARA, XPERSWING
DARCA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100039, China

Location

Related Publications (7)

  • 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.

    PMID: 19180661BACKGROUND

  • 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.

    PMID: 15170705BACKGROUND

  • 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.

    PMID: 20826266BACKGROUND

  • 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.

    PMID: 22465608BACKGROUND

  • 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.

    PMID: 22105940BACKGROUND

  • 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.

    PMID: 20853352RESULT

  • 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.

    PMID: 22613524RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Liu Huiliang, M.D.

    Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China

    STUDY CHAIR

  • Jin Zhigeng, M.M.

    Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China

    STUDY DIRECTOR

  • Luo Jianping, M.M.

    Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China

    PRINCIPAL INVESTIGATOR

  • Yang Shengli, M.D.

    Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China

    PRINCIPAL INVESTIGATOR

  • Ma Dongxing, M.D.

    Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China

    PRINCIPAL INVESTIGATOR

  • Liu Ying, M.M.

    Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China

    PRINCIPAL INVESTIGATOR

  • Han Wei, M.D.

    Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China

    PRINCIPAL INVESTIGATOR

  • Jing Limin, B.S.M.

    Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 21, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

CN(1)