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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Coronary Angiography

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Angiography, Rotational Coronary Angiography, Contrast Media, Radiation, Quantitative Coronary Angiography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

General hospital of Chinese people's armed police forces

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Coronary Angiography

Arm Description

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).

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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)

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.

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.

Full Information

NCT ID

NCT01776866

First Posted

January 16, 2013

Last Updated

June 27, 2015

Sponsor

General Hospital of Chinese Armed Police Forces

1. Study Identification

Unique Protocol Identification Number

NCT01776866

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

General Hospital of Chinese Armed Police Forces

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary Angiography, Rotational Coronary Angiography, Contrast Media, Radiation, Quantitative Coronary Angiography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Coronary Angiography

Arm Type

Other

Arm Description

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).

Intervention Type

Procedure

Intervention Name(s)

Coronary Angiography

Intervention Description

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.

Primary Outcome Measure Information:

Title

Diagnosis of Coronary Heart Disease

Description

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%.

Time Frame

After coronary angiography, an expected average of 1 month

Secondary Outcome Measure Information:

Title

Coronary Lesion Assessment

Description

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)

Time Frame

After coronary angiography, an expected average of 1 month

Title

Quantitative Coronary Angiography

Description

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.

Time Frame

After coronary angiography, an expected average of 1 month

Title

Diagnostic Screening Adequacy

Description

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.

Time Frame

After coronary angiography, an expected average of 1 month

Other Pre-specified Outcome Measures:

Title

Safety Analysis

Description

The time(seconds), contrast usage(ml) and radiation dose(Gycm2) are recorded from the point of selective catheter engagement in the coronary ostium to the completion of the diagnostic study. The time, contrast and radiation to perform isocentering are included during dura-axis rotational coronary angiography. The time, contrast and radiation to engage the coronary ostium, exchange catheters, and perform non-coronary angiography are excluded from the analysis. All adverse events observed by the operator or reported by the patient are recorded.

Time Frame

During coronary angiography

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liu Huiliang, M.D.

Organizational Affiliation