Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439719
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
Plaque Composition in T2DM With and Without Microvascular Complications
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Differences in Plaque Composition Evaluated Through Coronary Tomography in Subjects With Type 2 Diabetes With and Without Microvascular Complications
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adults with diabetes mellitus have 2-3 times fold increased cardiovascular CV risk compared to adults without diabetes and the risk rises with the worsening of glycaemic control Adults with type 2 diabetes mellitus T2DM and microvascular complications DMCs have a higher risk of CV complications than subjects without DMCs 2023 European Society of Cardiology ESC guidelines stated that individuals with T2DM with target organ damage TOD defined as presence of microvascular disease in at least three different sites eg microalbuminuria stage A2 plus retinopathy plus neuropathy should be considered into a very high CV risk category
Coronary artery calcium score CACS is a measure of the amount of calcium deposits in the coronary arteries obtained through a CT coronary imaging CACS has become a widely available and accurate tool for determining the risk of major CV events
The specific role of DMCs in determining the features of coronary plaques is not completely known A recent study showed how T2DM subjects with obstructive coronary artery disease CAD with DMCs at their first coronary event present a more stable coronary atherosclerosis features at OCT-imaging as they have a higher prevalence of fibrous plaques and healed plaques with larger calcifications compared to those with T2DM and no DMCs In this study only subjects with obstructive CAD defined as a stenosis 50 in the left main coronary artery or any stenosis 70 or fractional flow reserve 080 in any other major epicardial vessel were enrolled
Therefore further research to evaluate differences in CACS in T2DM subjects with no previous history of CAD with and without DMCs is required
Aim of our study was to evaluate the presence of differences in the distribution and tomographic features of coronary plaques in T2DM subjects with no previous history of CAD with at least one DMCs focusing on the degree of plaque calcification calculated by the CACS
Coronary artery calcium score CACS is a measure of the amount of calcium deposits in the coronary arteries obtained through a CT coronary imaging CACS has become a widely available and accurate tool for determining the risk of major CV events
The specific role of DMCs in determining the features of coronary plaques is not completely known A recent study showed how T2DM subjects with obstructive coronary artery disease CAD with DMCs at their first coronary event present a more stable coronary atherosclerosis features at OCT-imaging as they have a higher prevalence of fibrous plaques and healed plaques with larger calcifications compared to those with T2DM and no DMCs In this study only subjects with obstructive CAD defined as a stenosis 50 in the left main coronary artery or any stenosis 70 or fractional flow reserve 080 in any other major epicardial vessel were enrolled
Therefore further research to evaluate differences in CACS in T2DM subjects with no previous history of CAD with and without DMCs is required
Aim of our study was to evaluate the presence of differences in the distribution and tomographic features of coronary plaques in T2DM subjects with no previous history of CAD with at least one DMCs focusing on the degree of plaque calcification calculated by the CACS
Detailed Description:
Subjects with T2DM who performed CT coronary imaging as per clinical routine practice
They will be therefore divided into two groups
Group A subjects with T2DM with at least one DMC as defined
Retinopathy defined as any diabetes related eye disease macular oedema severe non proliferative diabetic retinopathy proliferative diabetic retinopathy or previous history of retinal photocoagulation therapy andor intravitreal injections of anti- vascular endothelial growth factor VEGF agents
Neuropathy including any diabetes-related neurological complication diabetic peripheral neuropathy diabetic autonomic neuropathy
Nephropathy defined as the presence of albuminuria urinary albumin 30 mgg creatinine andor an estimated glomerular filtration rate 60 mLmin173 m2
Group B subjects with T2DM without DMCs
Following data will be collected Anthropometric parameters
Sex
Year of birth
Height expressed in m
Weight expressed in Kg
BMI calculated as weight divided by height squared
Vital signs
Blood pressure expressed in mmHg
Heart rate expressed in bpm
VFA Visceral fat area - cm2
SFA subcutaneous fat area - cm2
Medical history
Date of diagnosis of diabetes at least the year
Comorbidities
Year of diagnosis of comorbidities
Smoking habits defined as current smoker former smoker never smoked
Medications
Diabetes medications
Dose of each diabetes medications
Year of start for each diabetes medications
Concomitant medications
Dose of each concomitant medications
Year of start for each concomitant medication
Cardiovascular risk scores
SCORE2-Diabetes 12
Blood Tests data collection
HbA1c
Serum Creatinine
Total Cholesterol
LDL Cholesterol
HDL Cholesterol
Triglycerides
Transaminases
Microalbuminuria
Blood sample collection CRP
Cardiovascular Autonomic Tests
Following Cardiovascular autonomic tests will be performed
Deep breathing The patient sits quietly and breathes deeply at six breaths a minute five seconds in and five seconds out for one minute An electrocardiogram is recorded throughout the period of deep breathing with a marker used to indicate the onset of each inspiration and expiration
Valsalva manoeuvre The test is performed by the patient blowing into a mouth- piece connected to an aneroid manometer or a modified sphygmomanometer and holding it at a pressure of 40 mm Hg for 15 seconds while a continuous electrocardiogram is recorded The manoeuvre is performed three times with one- minute intervals between
Lying to standing The test is performed by measuring the patients blood pressure with a sphygmomanometer while he is lying down quietly and again when he stands up The postural fall in blood pressure is taken as the difference between the systolic blood pressure lying and the systolic blood pressure standing 13
Neuropathy evaluation
Michigan Neuropathy Screening Instrument MNSI-Q questionnaire 14
COMPASS31 questionnaire 15
Diabetic Neuropathy Index DNI questionnaire 16
DN4 questionnaire 17
Monofilament examination
Ophthalmologic evaluation
Non mydriatic Ocular fundus photography
Coronary CTA parameters collection
Total EAT
EAT of atrio_ventricular sulcus
EAT of anterior interventricular artery both as volume and thickness
EAT of right coronary artery
EAT of circumfl ex coronary artery
EAT Volume Index cm3m2
Perivascular FAI -30 -190 UH
CACS Agatston score Volume and mass
Plaque gradingstenosis Minimum mild intermediate Severe using CAD-RADS 20
Plaque characteristics non-calcific mixed and calcific plaque evaluating any high-risk plaque profile
They will be therefore divided into two groups
Group A subjects with T2DM with at least one DMC as defined
Retinopathy defined as any diabetes related eye disease macular oedema severe non proliferative diabetic retinopathy proliferative diabetic retinopathy or previous history of retinal photocoagulation therapy andor intravitreal injections of anti- vascular endothelial growth factor VEGF agents
Neuropathy including any diabetes-related neurological complication diabetic peripheral neuropathy diabetic autonomic neuropathy
Nephropathy defined as the presence of albuminuria urinary albumin 30 mgg creatinine andor an estimated glomerular filtration rate 60 mLmin173 m2
Group B subjects with T2DM without DMCs
Following data will be collected Anthropometric parameters
Sex
Year of birth
Height expressed in m
Weight expressed in Kg
BMI calculated as weight divided by height squared
Vital signs
Blood pressure expressed in mmHg
Heart rate expressed in bpm
VFA Visceral fat area - cm2
SFA subcutaneous fat area - cm2
Medical history
Date of diagnosis of diabetes at least the year
Comorbidities
Year of diagnosis of comorbidities
Smoking habits defined as current smoker former smoker never smoked
Medications
Diabetes medications
Dose of each diabetes medications
Year of start for each diabetes medications
Concomitant medications
Dose of each concomitant medications
Year of start for each concomitant medication
Cardiovascular risk scores
SCORE2-Diabetes 12
Blood Tests data collection
HbA1c
Serum Creatinine
Total Cholesterol
LDL Cholesterol
HDL Cholesterol
Triglycerides
Transaminases
Microalbuminuria
Blood sample collection CRP
Cardiovascular Autonomic Tests
Following Cardiovascular autonomic tests will be performed
Deep breathing The patient sits quietly and breathes deeply at six breaths a minute five seconds in and five seconds out for one minute An electrocardiogram is recorded throughout the period of deep breathing with a marker used to indicate the onset of each inspiration and expiration
Valsalva manoeuvre The test is performed by the patient blowing into a mouth- piece connected to an aneroid manometer or a modified sphygmomanometer and holding it at a pressure of 40 mm Hg for 15 seconds while a continuous electrocardiogram is recorded The manoeuvre is performed three times with one- minute intervals between
Lying to standing The test is performed by measuring the patients blood pressure with a sphygmomanometer while he is lying down quietly and again when he stands up The postural fall in blood pressure is taken as the difference between the systolic blood pressure lying and the systolic blood pressure standing 13
Neuropathy evaluation
Michigan Neuropathy Screening Instrument MNSI-Q questionnaire 14
COMPASS31 questionnaire 15
Diabetic Neuropathy Index DNI questionnaire 16
DN4 questionnaire 17
Monofilament examination
Ophthalmologic evaluation
Non mydriatic Ocular fundus photography
Coronary CTA parameters collection
Total EAT
EAT of atrio_ventricular sulcus
EAT of anterior interventricular artery both as volume and thickness
EAT of right coronary artery
EAT of circumfl ex coronary artery
EAT Volume Index cm3m2
Perivascular FAI -30 -190 UH
CACS Agatston score Volume and mass
Plaque gradingstenosis Minimum mild intermediate Severe using CAD-RADS 20
Plaque characteristics non-calcific mixed and calcific plaque evaluating any high-risk plaque profile
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None