Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579807
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Cardiac Rehabilitation and Coronary Artery Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of a Cardiovascular Rehabilitation Program on Atherosclerosis Endothelial Function and Inflammation in Patients With Coronary Artery Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Patients with coronary artery disease CAD aged 40-70 years will undergo exercise training thrice weekly for 12 weeks A reference group composed of healthy individuals will be included Evaluations will be conducted at baseline and after the intervention period during two visits During the first visit carotid artery thickness will be assessed via ultrasound before and after a cardiopulmonary exercise testing The second visit will include the evaluation of endothelial function using venous occlusion plethysmography After this participants will engage in 30 minutes of moderate-intensity aerobic exercise and blood samples will be collected pre- and post-exercise Circulating levels of kynurenine pathway KP metabolites Tryptophan kynurenine kynurenic acid and quinolinic acid pro-inflammatory cytokines cell adhesion molecules and lipid profiles will be measured via Enzyme-Linked Immunosorbent Assay ELISA multiplex essays and biochemical analysis respectively
Detailed Description:
Participants and recruitment In this clinical trial 28 patients with CAD will be enrolled from the Pedro Ernesto University Hospital HUPE and 22 control volunteers without evidence of CAD CTL will be randomly recruited from among employees and students at the University of Rio de Janeiro State UERJ The groups will be matched by age and habitual physical activity level assessed by the Baecke questionnaire which quantifies activities performed at home work and leisure sports
All participants will receive oral and written instructions regarding the risks and benefits of the study and will provide written informed consent The study was approved by the Research Ethics Committee of HUPE CAAE 81718324300005259 The study also adheres to SPIRIT 2013 Standard Protocol Items Recommendations for International Trials
Study design Evaluations will be conducted at baseline and after the 12-week intervention period during two visits interspersed by at least 72-hours interval Outcomes in the CTL group will be assessed only at baseline to provide reference values Visits will take place at the Physical Activity and Health Promotion Laboratory LABSAU and the Clinical and Experimental Research Laboratory on Vascular Biology BioVasc always in the morning 800 - 1100 am in rooms with controlled temperatures between 22-24C and relative humidity between 60-70 Participants will be instructed to avoid physical activity alcohol and stimulants 48 hours prior to assessments
During the first visit volunteers will undergo a medical history assessment If eligible they will read and sign the informed consent form if they agree to participate Subsequently carotid intima-media thickness will be assessed via carotid ultrasound followed by a cardiopulmonary exercise testing CPET Immediately after the test carotid intima-media thickness will be reassessed
On the second visit patients will undergo blood collection after 8 hours of fasting followed by an assessment of vascular function using venous occlusion plethysmography Approximately 15 min after a light standardized breakfast participants will engage in 30 minutes of moderate-intensity aerobic exercise after which blood samples will be collected again
All participants will receive oral and written instructions regarding the risks and benefits of the study and will provide written informed consent The study was approved by the Research Ethics Committee of HUPE CAAE 81718324300005259 The study also adheres to SPIRIT 2013 Standard Protocol Items Recommendations for International Trials
Study design Evaluations will be conducted at baseline and after the 12-week intervention period during two visits interspersed by at least 72-hours interval Outcomes in the CTL group will be assessed only at baseline to provide reference values Visits will take place at the Physical Activity and Health Promotion Laboratory LABSAU and the Clinical and Experimental Research Laboratory on Vascular Biology BioVasc always in the morning 800 - 1100 am in rooms with controlled temperatures between 22-24C and relative humidity between 60-70 Participants will be instructed to avoid physical activity alcohol and stimulants 48 hours prior to assessments
During the first visit volunteers will undergo a medical history assessment If eligible they will read and sign the informed consent form if they agree to participate Subsequently carotid intima-media thickness will be assessed via carotid ultrasound followed by a cardiopulmonary exercise testing CPET Immediately after the test carotid intima-media thickness will be reassessed
On the second visit patients will undergo blood collection after 8 hours of fasting followed by an assessment of vascular function using venous occlusion plethysmography Approximately 15 min after a light standardized breakfast participants will engage in 30 minutes of moderate-intensity aerobic exercise after which blood samples will be collected again
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