Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603363
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Changes in Plaque Characteristics After Short-term Statin Therapy As Assessed with Coronary CT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Changes in Plaque Characteristics After Short-term Statin Therapy As Assessed with Coronary CT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTENSE
Brief Summary:
INTENSE Trial is a prospective double-blind randomized placebo-controlled single-center study with two arms 40 mg intensified statin therapy vs matching placebo for rosuvastatin among statin-naive patients referred to coronary CT angiography due to stable chest pain followed for 24 months by using a photon-counting detector CT PCD-CT
INTENSE Trial aims 1 to assess the effect of short-term intensified statin therapy on coronary anatomy and physiology using PCD-CT and 2 to determine the impact of short-term intensified statin therapy on coronary plaque morphology and hemodynamics to identify statin responder and non-responder patients in addition to testing the hypothesis of plaque memory after the 24-month follow-up period
INTENSE Trial aims 1 to assess the effect of short-term intensified statin therapy on coronary anatomy and physiology using PCD-CT and 2 to determine the impact of short-term intensified statin therapy on coronary plaque morphology and hemodynamics to identify statin responder and non-responder patients in addition to testing the hypothesis of plaque memory after the 24-month follow-up period
Detailed Description:
The extent to which short-term intensified statin treatment may modulate plaque lipid content alter plaque structure and change flow physiology as assessed by non-invasive imaging remains unknown Furthermore no data is available regarding the effects of short-term intensified statin therapy on coronary plaques as assessed by Photon-Counting Detector CT PCD-CT In addition no data is available regarding the long-term effects of short intensified statin therapy on plaque morphology ie plaque memory Therefore in this randomized controlled prospective double-blind single-center clinical trial we aimed 1 to assess the effect of short-term intensified statin therapy on coronary anatomy and physiology using PCD-CT and 2 to assess the effect of short intensified statin treatment on long term changes in plaque characteristics In other words to test our plaque memory hypothesis Our analyses include a detailed evaluation of plaques by combining anatomic quantitative and qualitative plaque assessment radiomics and hemodynamic Fractional Flow Reserve-CT FFR-CT information
In this randomized controlled prospective double-blinded single-center clinical trial we aim to enroll statin naive patients patients with no previous or current statin treatment who underwent PCD-CT NAEOTOM Alpha Siemens Healthineers Erlangen Germany exam due to stable chest pain and suspected coronary artery disease CAD at the Medical Imaging Centre of Semmelweis University Budapest Hungary Coronary CT Angiography Coronary CTA examinations will be performed in accordance with the current guidelines of the Society of Cardiovascular Computed Tomography
We will enroll patients aged 30-65 years with at least one partially calcified or non-calcified plaque and with negative FFR-CT FFR-CT075 distal to stenosis
Patients with contraindications to coronary CTA and patients post-revascularisation will be excluded from the study Additional exclusion criteria patients receiving lipid-lowering therapy before coronary CTA exam alanine aminotransferase ALT levels 3 upper limit of normal ULN unexplained serum creatine kinase CK level 3 ULN serum creatinine 2 mgdL 177 umoll elevated low-density lipoprotein LDL level 5 mmolL
Patients will be randomized into high-dose statin and placebo groups considering the age and sex of the patients to achieve equal representation of age groups and genders in both arms Based on the sample size calculation 70-70 patients must be randomized into each group For those who will be randomized to the high-dose statin group 40 mg rosuvastatin therapy will be initiated For those who will be randomized to the placebo group a placebo therapy will be started with medications that look the same as 40 mg rosuvastatin pills
All the included patients will undergo repeated coronary CTA at 3 months and 24 months after the baseline CT After the 3-month coronary CTA control rosuvastatin dose per standard of care will be initiated The 3-month and 24-month control coronary CTA evaluations will be the same as the baseline CT scans All coronary CTA exams will be performed using a low radiation dose protocol utilizing the advanced imaging capabilities of PCD-CT
All the included patients will undergo repeated coronary CTA at 3 months and 24 months after the baseline CT with a standardized acquisition protocol
Proposed scan parameters for all patients are as follows tube voltage 120 kVp due to improved spectral data automatic tube current modulation with image quality level IQ-level 80 detector configuration 144 mm 04 mm rotation time 025 s All coronary CTA exams will be performed by using a low radiation dose protocol utilizing the advanced imaging capabilities of PCD-CT
Patients may receive intravenous or oral beta blockers if their heart rate HR is 65 beatsminute before the examination All patients will receive a nitroglycerine transdermal patch before CTA scanning if systolic blood pressure is 100 Hgmm Prospectively triggered acquisition mode is preferred in case of regular HR 70 beatsmin and helical scan mode if HR is irregular Images will be acquired in diastole 65-85 of the R-R interval or systole 200-400 ms depending on the HR or 75 beatsminute A four-phasic contrast injection protocol with 70-80 mL contrast agent at a flow rate of 45-50 mLs is recommended
Special attention will be given to ensure that the baseline CT scan parameters are consistent with the follow-up scans for each patient Images and coronary segments with severe motion breathing beam-hardening or misalignment artifacts will be excluded from the analysis Coronary segments matched to the segment with artifacts will also be excluded in all scans
The primary endpoint will be evaluated at 3 months while plaque memory will be assessed at 24 months of follow-up
In this randomized controlled prospective double-blinded single-center clinical trial we aim to enroll statin naive patients patients with no previous or current statin treatment who underwent PCD-CT NAEOTOM Alpha Siemens Healthineers Erlangen Germany exam due to stable chest pain and suspected coronary artery disease CAD at the Medical Imaging Centre of Semmelweis University Budapest Hungary Coronary CT Angiography Coronary CTA examinations will be performed in accordance with the current guidelines of the Society of Cardiovascular Computed Tomography
We will enroll patients aged 30-65 years with at least one partially calcified or non-calcified plaque and with negative FFR-CT FFR-CT075 distal to stenosis
Patients with contraindications to coronary CTA and patients post-revascularisation will be excluded from the study Additional exclusion criteria patients receiving lipid-lowering therapy before coronary CTA exam alanine aminotransferase ALT levels 3 upper limit of normal ULN unexplained serum creatine kinase CK level 3 ULN serum creatinine 2 mgdL 177 umoll elevated low-density lipoprotein LDL level 5 mmolL
Patients will be randomized into high-dose statin and placebo groups considering the age and sex of the patients to achieve equal representation of age groups and genders in both arms Based on the sample size calculation 70-70 patients must be randomized into each group For those who will be randomized to the high-dose statin group 40 mg rosuvastatin therapy will be initiated For those who will be randomized to the placebo group a placebo therapy will be started with medications that look the same as 40 mg rosuvastatin pills
All the included patients will undergo repeated coronary CTA at 3 months and 24 months after the baseline CT After the 3-month coronary CTA control rosuvastatin dose per standard of care will be initiated The 3-month and 24-month control coronary CTA evaluations will be the same as the baseline CT scans All coronary CTA exams will be performed using a low radiation dose protocol utilizing the advanced imaging capabilities of PCD-CT
All the included patients will undergo repeated coronary CTA at 3 months and 24 months after the baseline CT with a standardized acquisition protocol
Proposed scan parameters for all patients are as follows tube voltage 120 kVp due to improved spectral data automatic tube current modulation with image quality level IQ-level 80 detector configuration 144 mm 04 mm rotation time 025 s All coronary CTA exams will be performed by using a low radiation dose protocol utilizing the advanced imaging capabilities of PCD-CT
Patients may receive intravenous or oral beta blockers if their heart rate HR is 65 beatsminute before the examination All patients will receive a nitroglycerine transdermal patch before CTA scanning if systolic blood pressure is 100 Hgmm Prospectively triggered acquisition mode is preferred in case of regular HR 70 beatsmin and helical scan mode if HR is irregular Images will be acquired in diastole 65-85 of the R-R interval or systole 200-400 ms depending on the HR or 75 beatsminute A four-phasic contrast injection protocol with 70-80 mL contrast agent at a flow rate of 45-50 mLs is recommended
Special attention will be given to ensure that the baseline CT scan parameters are consistent with the follow-up scans for each patient Images and coronary segments with severe motion breathing beam-hardening or misalignment artifacts will be excluded from the analysis Coronary segments matched to the segment with artifacts will also be excluded in all scans
The primary endpoint will be evaluated at 3 months while plaque memory will be assessed at 24 months of follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None