Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290544
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-03-30
Brief Title:
Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus CARDT1
Sponsor:
Centro Cardiologico Monzino
Organization:
Centro Cardiologico Monzino
Study Overview
Official Title:
Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus - CARDT1
Status:
RECRUITING
Status Verified Date:
2023-10
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:
CARDT1
Brief Summary:
This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology ESCEuropean Association for the Study of Diabetes EASD guidelines and The Steno Type 1 Risk Engine algorithm The correlation between CVD risk atherosclerosis and microvascular complications of diabetes retinopathy nephropathy and neuropathy will then be evaluated and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus T1DM patients who meet all the inclusion criteria and none of exclusion criteria
Detailed Description:
Patients with type 1 diabetes mellitus will be identified in the electronic medical records and their clinical anthropometric and laboratory data including markers of glycemic variability and other blood glucose metrics will be collected Cardiovascular risk will then be assessed using the stratification proposed by ESCEASD and The Steno Type 1 Risk Engine
As suggested by the guidelines according to cardiovascular risk participants will perform a coronary CT scan in order to investigate coronary anatomy to study the atherosclerotic plaque morphology to assess high-risk plaque characteristics and in case of obstructive coronary artery disease to investigate myocardial perfusion by adenosine infusion to assess both ischemia and microcirculation dysfunction Noninvasive B-mode ultrasonography of the supra-aortic trunks will assess for signs of carotid atherosclerosis ie carotid intima media thickness - c-IMT - and carotid plaques Ankle-arm index ABI a noninvasive cardiovascular bio-marker will provide information on peripheral arterial disease Endothelial function will be also assessed using the ENDO-PAT 2000 instrument which measures endothelial dysfunction with a peripheral arterial tone detection method
For the purpose of assessing participants nutritional habits participants will be asked to complete the Food Frequency Questionnaire FFQ the week prior the visit once the FFQ will be completed an interview with the nutritionist will be scheduled in order to review and to ascertain its completeness in addition the PREDIMED questionnaire for calculating the Mediterranean Diet Adherence Screener score MEDAS will be administered to assess adherence to the Mediterranean diet
An interview with the psychologist will be planned During that visit the participant will receive information about the rationale of the study regarding psychological aspects the questionnaires that will be administered and how to fill them out correctly online via the Qualtrics EU platform The Iowa Gambling Task IGT test will then be administered
Finally biological samples will be collected for future genomic and epigenetic analyses associated with different cardiovascular disease CVD phenotypes and outcomes
As suggested by the guidelines according to cardiovascular risk participants will perform a coronary CT scan in order to investigate coronary anatomy to study the atherosclerotic plaque morphology to assess high-risk plaque characteristics and in case of obstructive coronary artery disease to investigate myocardial perfusion by adenosine infusion to assess both ischemia and microcirculation dysfunction Noninvasive B-mode ultrasonography of the supra-aortic trunks will assess for signs of carotid atherosclerosis ie carotid intima media thickness - c-IMT - and carotid plaques Ankle-arm index ABI a noninvasive cardiovascular bio-marker will provide information on peripheral arterial disease Endothelial function will be also assessed using the ENDO-PAT 2000 instrument which measures endothelial dysfunction with a peripheral arterial tone detection method
For the purpose of assessing participants nutritional habits participants will be asked to complete the Food Frequency Questionnaire FFQ the week prior the visit once the FFQ will be completed an interview with the nutritionist will be scheduled in order to review and to ascertain its completeness in addition the PREDIMED questionnaire for calculating the Mediterranean Diet Adherence Screener score MEDAS will be administered to assess adherence to the Mediterranean diet
An interview with the psychologist will be planned During that visit the participant will receive information about the rationale of the study regarding psychological aspects the questionnaires that will be administered and how to fill them out correctly online via the Qualtrics EU platform The Iowa Gambling Task IGT test will then be administered
Finally biological samples will be collected for future genomic and epigenetic analyses associated with different cardiovascular disease CVD phenotypes and outcomes
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