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The FLOW-PROMOTE Study is an investigator-initiated, Danish multicenter study of patients with stable chest pain investigating whether lipid lowering is associated with recovery of impaired coronary flow as assessed by CT derived fractional flow reserve (FFRCT).
Multicenter study (4 centers in Denmark), including 120 patients with stable chest pain and hemodynamically significant coronary artery disease as assessed by FFRCT. By using two lipid lowering treatment strategies ("usual" vs "intensive" care) over 18 months, the effect on coronary plaque regression and flow recovery are assessed from repeated CT angiograms with plaque and FFRCT analyses at 9 and 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Usual care" | Active Comparator | "Usual care" prevention: atorvastatin 40 mg per day for 18 months |
|
| "Intensive care" | Experimental | "Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin 40mg | Drug | Rosuvastatin 40 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 18-month change in coronary flow | Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 18-month change high risk coronary plaque volumes | Will be assessed by measuring low attenuation coronary plaque (LAP) volumes at repetitive CT angiograms (0,9, and 18 months) | 18 months |
| 18-month change in high risk coronary plaque features |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility assessment | There will be performed 2 CTA investigations at the 9 month follow-up. Reproducibility assessment of CT derived FFR, plaque markers, FAI and V/M ratio will be performed by calculation of standard error of measurement and within-subject coefficient of variation. | 9-months |
Inclusion Criteria:
5. LDL cholesterol >2.0 mM (patients already on lipid lowering medical therapy < 3 months can be included if meeting all of the above mentioned criteria)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bjarne L Noergaard, MD, PhD | Contact | +4540136570 | bnorgaard@dadlnet.dk | |
| Martin B Mortensen, MD, PhD | Contact | +4523882155 | martin.bodtker.mortensen@clin.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Bjarne L Noergaard, MD, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8200 N | Denmark |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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Patients are randomized 1:1 to two different lipid lowering medical treatment strategies
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Open label design
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Will be assessed by quantifying the proportion of lesions with positive remodeling at repetitive CT angiograms (0,9, and 18 months).
| 18-months |
| 18-month change in coronary vessel volumes | Will be assessed by calculating the vessel volume relative to myocardial mass (V/M) ratio determined from repetitive CT angiograms (0,9, and 18 months). | 18-months |
| 18-month change in indices of coronary inflammation | Will be assessed by the pericoronary fat attenuation index (FAI) determined from repetitive CT angiograms (0,9, and 18 months). | 18-months |
| Southwestern Hospital Esbjerg | Recruiting | Esbjerg | 6700 | Denmark |
|
| Lillebaelt Hospital | Not yet recruiting | Vejle | 7100 | Denmark |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001384 | Azetidines |
| D001385 | Azetines |