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| Name | Class |
|---|---|
| AZ Delta | OTHER |
| University Hospital, Antwerp | OTHER |
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Although concomitant coronary artery disease (CAD) is frequent in patients with severe aortic stenosis (AS), hemodynamic assessment of CAD severity in patients undergoing valve replacement for severe AS is challenging. Myocardial hypertrophic remodeling interferes with coronary blood flow and may influence the values of fractional flow reserve (FFR) and nonhyperemic pressure ratios (NHPRs). The aim of the current study is to investigate the effect of the AS and its treatment on current indices used for evaluation of CAD. The investigators will compare intracoronary hemodynamics before, immediately after, and 6 mo after aortic valve replacement (AVR) when it is expected that microvascular function has improved. Furthermore, the investigators will compare FFR and resting full-cycle ratio (RFR) with myocardial perfusion single-photon emission-computed tomography (SPECT) as indicators of myocardial ischemia in patients with AS and CAD. One-hundred consecutive patients with AS and intermediate CAD will be prospectively included. Patients will undergo pre-AVR SPECT and intracoronary hemodynamic assessment at baseline, immediately after valve replacement [if transcatheter AVR (TAVR) is chosen], and 6 mo after AVR. The primary end point is the change in FFR 6 mo after AVR. Secondary end points include the acute change of FFR after TAVR, the diagnostic accuracy of FFR versus RFR compared with SPECT for the assessment of ischemia, changes in microvascular function as assessed by the index of microcirculatory resistance (IMR), and the effect of these changes on FFR. The present study will evaluate intracoronary hemodynamic parameters before, immediately after, and 6 mo after AVR in patients with AS and intermediate coronary stenosis. The understanding of the impact of AVR on the assessment of FFR, NHPR, and microvascular function may help guide the need for revascularization in patients with AS and CAD planned for AVR.
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| Measure | Description | Time Frame |
|---|---|---|
| FFR 6 Months After SAVR/TAVI. | Aortic valve intervention can potentially result in a change in fractional flow reserve (FFR) 6 months after SAVR/TAVI. FFR is the ratio of two intra-coronary measurements (Distal coronary pressure divided by proximal coronary pressure) and can range from 0.0-1.0. A lower FFR means that the lesion is more severe and therefore a higher FFR is considered better. The threshold to speak about hemodynamic significant of a lesion is 0.80. If the lesion has an FFR of ≤ 0.80 means the lesions is significant and treatment is necessary. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| IMR 6 Months After SAVR/TAVI. | Measurement of IMR in patients with AS prior to intervention and 6 months after TAVI/SAVR. IMR is unitless and gives a description of coronary microvascular resistance, it can range from 0-100. Lower values are considered better as they are related with better microvascular function and health. If the IMR > 25 we say microvascular dysfunction is present and treatment is considered necessary. |
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Inclusion Criteria:
1. Patient undergoing the procedure is older than 18 years, has severe aortic valve stenosis (according to ESC guidelines) and is planned for cardiac catheterization as part of the pre-operative (SAVR) or pre-percutaneous (TAVI) work up.
2. The patient has an intermediate (50-90%) coronary lesion that requires further evaluation.
3. The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.
Exclusion Criteria:
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Patients undergoing routine cardiac catheterization during preparation for TAVI or SAVR, who are found to have coronary artery disease, will be approached to take part.
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Dubois, MD, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams-brabant | 3000 | Belgium | ||
| University hospital Antwerp |
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| Label | URL |
|---|---|
| Rationale and Design paper | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Entire Study Population | Patients with AS undergoing TAVI or SAVR |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Entire study population
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Patients with AS undergoing TAVI or SAVR |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FFR 6 Months After SAVR/TAVI. | Aortic valve intervention can potentially result in a change in fractional flow reserve (FFR) 6 months after SAVR/TAVI. FFR is the ratio of two intra-coronary measurements (Distal coronary pressure divided by proximal coronary pressure) and can range from 0.0-1.0. A lower FFR means that the lesion is more severe and therefore a higher FFR is considered better. The threshold to speak about hemodynamic significant of a lesion is 0.80. If the lesion has an FFR of ≤ 0.80 means the lesions is significant and treatment is necessary. | Posted | Mean | Standard Deviation | ratio | 6 months |
|
From inclusion to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Entire Study Population | Patients with AS undergoing TAVI or SAVR | 0 |
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First, microvascular function analysis was based on bolus-thermodilution,recent studies have shown that continuous coronary thermodilution may have better reproducibility. Second, myocardial perfusion SPECT is not the gold standard for non-invasive detection of ischemia.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lennert Minten | UZ Leuven | +32496397568 | lennert.minten@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2021 | Jun 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Before IMR measurement, a peripheral blood sample (10cc EDTA, citrate and 2.5mL PaxGene® RNA tube) will be obtained to assess platelet function and for biomarker evaluation (RNA analysis).
| 6 months |
| FFR Versus RFR to Determine Ischemia. | Comparison of the diagnostic performance of FFR versus RFR compared with SPECT ischemia. The higher the Area under the curve the better. The range is 0.0-1.0. An area under the curve for a ROC model is considered excellent if > 0.8. | Baseline |
| Antwerp |
| Belgium |
| AZ Delta | Roeselare | Belgium |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Secondary | IMR 6 Months After SAVR/TAVI. | Measurement of IMR in patients with AS prior to intervention and 6 months after TAVI/SAVR. IMR is unitless and gives a description of coronary microvascular resistance, it can range from 0-100. Lower values are considered better as they are related with better microvascular function and health. If the IMR > 25 we say microvascular dysfunction is present and treatment is considered necessary. | Posted | Mean | Standard Deviation | Unitless | 6 months |
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| Secondary | FFR Versus RFR to Determine Ischemia. | Comparison of the diagnostic performance of FFR versus RFR compared with SPECT ischemia. The higher the Area under the curve the better. The range is 0.0-1.0. An area under the curve for a ROC model is considered excellent if > 0.8. | Posted | Number | 95% Confidence Interval | probability | Baseline |
|
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| 116 |
| 0 |
| 116 |
| 0 |
| 116 |
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| D014694 |
| Ventricular Outflow Obstruction |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |