Replacement of invasive diagnostic coronary procedures by innovative noninvasive Imaging Technologies

Replacement of invasive diagnostic coronary procedures by innovative noninvasive Imaging Technologies - REPLACE-IT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47060

Enrollment

440

Registered

2016-08-23

Start date

2018-11-05

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Atherosclerosis Coronary artery disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Planned for a ICA as part of standard clinical care for evaluation of suspected CAD - Age >=18 years

Exclusion criteria

Exclusion criteria: - Unable to provide written informed consent - ICA planned for other reasons than suspected obstructive CAD (e.g. screening prior to lung transplantation, valvular surgery, or ICD implantation) - Significant arrhythmia deemed to interfer with successful ECG triggered non-invasive imaging as judged by a cardiologist. - Renal insufficiency: GFR 35 kg/m2).

Design outcomes

Primary

Measure	Time frame
The diagnostic accuracy of non-invasive cardiac imaging in comparison to ICA.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints We will establish an database with CTA and MR perfusion imaging data to further develop evaluation techniques to estimate ischemia and predict future risk of events. We will acquire data in order to at least be able to determine the CT and MR parameters as listed below but also expect that emerging post-hoc image analyses will allow further evaluation, analysis and interpretation of the generated data. With CT data we will be able to calculate the Agatston score (Coronary Calcium Score). This score uses a weighted density score in which every intracoronary calcification >130 Houndsfield units (HU) is scored, weighted by the density of the attenuation, and multiplied by the area. Coronary calcifications with 130-199, 200-299, 300-399, or >400 will receive a weighting score of 1, 2, 3, or 4, respectively. The cumulative calcium score will be used for risk stratification and the following groups will be determined: 0 (extremely low risk of CAD), 1-99 (low risk of CAD), 100-399 (high risk of CAD), or >400 (extremely high risk of CAD). The 15-segment tree American Heart Association will be used in the definition of the coronary segments. In visual analysis the coronary arteries will be qualified binary (stenotic or normal) and categorical as percentage of vessel occlusion (0-29%, 30-49%, 50-69%, 70-99%, or 100%). Cut-off value for significant CAD will be >=70%. Coronary CTA series will be reviewed for presence and severity of coronary stenosis, in a quantitative manner, using software from partners. Beta software being developed by one of the partners will be used to calculate CT FFR on site. CT FFR will be assessed on a per-patient and per-vessel basis. MR examination Left ventricular volume (diastolic and systolic), mass, and ejection fraction will be calculated by manual tracing of the epicardial and endocardial outlines. Quantitative, semi-quantitative and visual analysis of myocardial perfusion will b	—

Measure

Time frame

Secondary study parameters/endpoints We will establish an database with CTA and MR perfusion imaging data to further develop evaluation techniques to estimate ischemia and predict future risk of events. We will acquire data in order to at least be able to determine the CT and MR parameters as listed below but also expect that emerging post-hoc image analyses will allow further evaluation, analysis and interpretation of the generated data. With CT data we will be able to calculate the Agatston score (Coronary Calcium Score). This score uses a weighted density score in which every intracoronary calcification >130 Houndsfield units (HU) is scored, weighted by the density of the attenuation, and multiplied by the area. Coronary calcifications with 130-199, 200-299, 300-399, or >400 will receive a weighting score of 1, 2, 3, or 4, respectively. The cumulative calcium score will be used for risk stratification and the following groups will be determined: 0 (extremely low risk of CAD), 1-99 (low risk of CAD), 100-399 (high risk of CAD), or >400 (extremely high risk of CAD). The 15-segment tree American Heart Association will be used in the definition of the coronary segments. In visual analysis the coronary arteries will be qualified binary (stenotic or normal) and categorical as percentage of vessel occlusion (0-29%, 30-49%, 50-69%, 70-99%, or 100%). Cut-off value for significant CAD will be >=70%. Coronary CTA series will be reviewed for presence and severity of coronary stenosis, in a quantitative manner, using software from partners. Beta software being developed by one of the partners will be used to calculate CT FFR on site. CT FFR will be assessed on a per-patient and per-vessel basis. MR examination Left ventricular volume (diastolic and systolic), mass, and ejection fraction will be calculated by manual tracing of the epicardial and endocardial outlines. Quantitative, semi-quantitative and visual analysis of myocardial perfusion will b

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Countries

Netherlands

Outcome results