The ''CORE-64'' Study.

Coronary Evaluation Using Multi-detector Spiral Computed Tomography Angiography using 64 Detectors.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21519

Enrollment

Registered

2005-11-24

Start date

2006-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Multicenter, clinical study.

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients; 2. age 40 years or greater; 3. suspected or diagnosed coronary artery disease with a clinical indication for coronary angiography and planned coronary angiography within the next 30 days; 4. able to understand and willing to sign the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Known allergy to iodinated contrast media; 2. history of contrast-induced nephropathy; 3. history of multiple myeloma or previous organ transplantation; 4. elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of 40.

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 50% in a patient with suspected coronary artery disease, compared with conventional coronary angiography.	—

Secondary

Measure	Time frame
The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 70% in a patient with suspected coronary artery disease compared with conventional coronary angiography. The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 50% in a single coronary vessel, compared with conventional coronary angiography. The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 70% in a single coronary vessel, compared with conventional coronary angiography The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 50% in a specific proximal coronary segment, compared with conventional coronary angiography The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 70% in a specific proximal coronary segment, compared with conventional coronary angiography Predictive ability of MDCTA for cardiovascular clinical events within 6 months and 1 year, compared with conventional coronary angiography. The diagnostic accuracy of MDCTA for determining the degree of stenosis (continuous variable) per coronary vessel relative to conventional coronary angiography. The accuracy of on-site versus central reading of MDCTA.	—

Measure

Time frame

The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 70% in a patient with suspected coronary artery disease compared with conventional coronary angiography. The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 50% in a single coronary vessel, compared with conventional coronary angiography. The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 70% in a single coronary vessel, compared with conventional coronary angiography The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 50% in a specific proximal coronary segment, compared with conventional coronary angiography The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 70% in a specific proximal coronary segment, compared with conventional coronary angiography Predictive ability of MDCTA for cardiovascular clinical events within 6 months and 1 year, compared with conventional coronary angiography. The diagnostic accuracy of MDCTA for determining the degree of stenosis (continuous variable) per coronary vessel relative to conventional coronary angiography. The accuracy of on-site versus central reading of MDCTA.

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Contacts

Public ContactA. Roos, de

Leiden University Medical Center (LUMC), Department of Radiology, Albinusdreef 2

+31 (0)71 5262993

Outcome results