Image Content Analysis of Dural-axis Rotational Versus Standard Coronary Angiography
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Purpose
The investigators hypothesized that dual-axis rotational coronary angiography was non-inferior to standard coronary angiography with respect to diagnosis of coronary artery disease.
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Procedure: Coronary Angiography |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Comparison of Image Content Assessment Between Dural-axis Rotational and Standard Coronary Angiography |
- Diagnosis of Coronary Heart Disease [ Time Frame: After the patient enrolment, an expected average of 1 week ] [ Designated as safety issue: No ]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%.
- Coronary Lesion Assessment [ Time Frame: After the patient enrolment, an expected average of 1 week ] [ Designated as safety issue: No ]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 >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)
- Diagnostic Screening Adequacy [ Time Frame: After the patient enrolment, an expected average of 1 week ] [ Designated as safety issue: No ]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.
- Quantitative Coronary Angiography [ Time Frame: After the patient enrolment, an expected average of 1 week ] [ Designated as safety issue: No ]The quantitative coronary angiography analysis of the >50% lesions detected by the lesion assessment of both angiographic modalities (lesion length, minimum lumen diameter, diameter stenosis).
- Safety Analysis [ Time Frame: During coronary angiography ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 70 |
| Study Start Date: | January 2013 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Coronary Angiography
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
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China | |
| General hospital of Chinese people's armed police forces | |
| Beijing, China, 100039 | |
| Study Chair: | Liu Huiliang, M.D. | General hospital of Chinese people's armed police forces |
| Study Director: | Jin Zhigeng, M.M. | General hospital of Chinese people's armed police forces |
| Principal Investigator: | 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 |
More Information
Publications:
| Responsible Party: | General Hospital of Chinese Armed Police Forces |
| ClinicalTrials.gov Identifier: | NCT01776866 History of Changes |
| Other Study ID Numbers: | 20130101, 20130101 |
| Study First Received: | January 16, 2013 |
| Last Updated: | May 14, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by General Hospital of Chinese Armed Police Forces:
|
Coronary Angiography Rotational Coronary Angiography Contrast Media Radiation Quantitative Coronary Angiography |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013