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Additional value of 3D rotation coronary angiography with the Allura 3D-CA system versus conventional coronary angiography. The COROTA trial.

Additional value of 3D rotation coronary angiography with the Allura 3D-CA system versus conventional coronary angiography. The COROTA trial. - COROTA- trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31002
Enrollment
50
Registered
2007-10-24
Start date
2007-08-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis coronary disease

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Patients suspected for coronary artery disease or with an acute coronary syndrome and therefore have to undergo a diagnostic coronary angiogram. -A written informed consent obtained. -Renal functions will be estimated by calculating the kreatinine clearance and glomerular filtration rate (GFR), according to the Cockroff-Gault formula before the procedure and where possible 24 hours after the procedure. The astimated kreatinine clearance must be > 90ml/min/1.73m2.

Exclusion criteria

Exclusion criteria: - age

Design outcomes

Primary

MeasureTime frame
- Qualitative and quantitative scoring for coronary stenosis (severity and numbers), coronary anatomy (left- or right system dominance; separate ostia LAD/CX; other coronary anomalies), TIMI-flow, thrombus, dissection and calcification. Qualitative stenosis scoring wil take place in the conventional projectings of the RCA and LCA and in the rotation projections of the RCA and LCA. The quantitative stenosis scooring will be performed with QCA software (quantitative coronary angiogram) on the conventional projections, the rotation images and with the Allura system on the created 3D coronairy model. -After the diagnostic coronary procedure, the obtained projections of the conventional projection, the rotation projection and the 3D reconstruction model are independently scored by 2 interventional cardiologists. -Patient characteristics and the obtained data from the coronary projections are analyzed in a database. -.

Secondary

MeasureTime frame
- Comparison will take place fore possible variations in used x-ray contrast fluid and radiation dose at the different projection techniques.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)