NCT01776866

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable coronary-artery-disease

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

January 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 30, 2015

Status Verified

June 1, 2015

Enrollment Period

4 months

First QC Date

January 16, 2013

Last Update Submit

June 27, 2015

Conditions

Coronary Artery Disease

Keywords

Coronary AngiographyRotational Coronary AngiographyContrast MediaRadiationQuantitative Coronary Angiography

Outcome Measures

Primary Outcomes (1)

  • 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%.

    After coronary angiography, an expected average of 1 month

Secondary Outcomes (3)

  • Coronary Lesion Assessment

    After coronary angiography, an expected average of 1 month

  • Quantitative Coronary Angiography

    After coronary angiography, an expected average of 1 month

  • Diagnostic Screening Adequacy

    After coronary angiography, an expected average of 1 month

Other Outcomes (1)

  • Safety Analysis

    During coronary angiography

Study Arms (1)

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).

Procedure: Coronary Angiography

Interventions

Coronary AngiographyPROCEDURE

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.

Coronary Angiography

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General hospital of Chinese people's armed police forces

Beijing, 100039, China

Location

Related Publications (4)

  • 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

  • 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: 20853352BACKGROUND

  • 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: 22613524BACKGROUND

  • 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.

    PMID: 31628576DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Liu Huiliang, M.D.

    General hospital of Chinese people's armed police forces

    STUDY CHAIR

  • Jin Zhigeng, M.M.

    General hospital of Chinese people's armed police forces

    STUDY DIRECTOR

  • Yang Shengli, M.D.

    General hospital of Chinese people's armed police forces

    PRINCIPAL INVESTIGATOR

  • Luo Jianping, M.M.

    General hospital of Chinese people's armed police forces

    PRINCIPAL INVESTIGATOR

  • Ma Dongxing, M.D.

    General hospital of Chinese people's armed police forces

    PRINCIPAL INVESTIGATOR

  • Liu Ying, M.M.

    General hospital of Chinese people's armed police forces

    PRINCIPAL INVESTIGATOR

  • Han Wei, M.D.

    General hospital of Chinese people's armed police forces

    PRINCIPAL INVESTIGATOR

  • Jing Limin, B.S.M.

    General hospital of Chinese people's armed police forces

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 28, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 30, 2015

Record last verified: 2015-06

Locations

CN(1)