Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640400
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Cardiovascular Ultrasound for the Rehabilitation of Patients With Coronary Heart Disease After PCI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Study of the Efficacy of Cardiovascular Ultrasound Therapy on the Rehabilitation of Patients After PCI for Coronary Artery Disease
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:
None
Brief Summary:
The goal of this clinical trial is to learn the efficacy of cardiovascular ultrasound therapy on the rehabilitation of patients with coronary heart disease after PCI It will also learn about the safety of cardiovascular ultrasound The main questions it aims to answer are
Whether cardiovascular ultrasound improves cardiac function and prognosis in patients with coronary artery disease after PCI What medical problems will participants experience after using cardiovascular ultrasound therapy Researchers will compare cardiovascular ultrasound to a placebo sham stimulation to see if cardiovascular ultrasound works to treat coronary artery disease after PCI
Participants will
Patients were treated with cardiovascular ultrasound or placebo from the 24th hour after PCI for 20 minutes twice a day for 10 days
Examination and detection of serum inflammatory markers endothelial function indicators cardiac function and heart rate variability at multiple time points baseline 24 hours post-PCI days 5 and 10 post-intervention and months 1 and 3
Their symptoms were recorded and depression and anxiety were scored
Whether cardiovascular ultrasound improves cardiac function and prognosis in patients with coronary artery disease after PCI What medical problems will participants experience after using cardiovascular ultrasound therapy Researchers will compare cardiovascular ultrasound to a placebo sham stimulation to see if cardiovascular ultrasound works to treat coronary artery disease after PCI
Participants will
Patients were treated with cardiovascular ultrasound or placebo from the 24th hour after PCI for 20 minutes twice a day for 10 days
Examination and detection of serum inflammatory markers endothelial function indicators cardiac function and heart rate variability at multiple time points baseline 24 hours post-PCI days 5 and 10 post-intervention and months 1 and 3
Their symptoms were recorded and depression and anxiety were scored
Detailed Description:
Background Coronary heart disease CHD is one of the leading causes of mortality and disability and places a financial burden on the healthcare system Although cardiovascular ultrasound has shown its effectiveness and safety in improving refractory angina relevant clinical studies are rare and clinical evidence is severely lacking
Methods and design This is a prospective parallel-group randomized control trial We will enroll 200 patients with coronary artery disease after PCI and randomize them into 2 groups The intervention group was given usual practice combined with cardiovascular ultrasound intervention and the control group was given usual practice combined with empty stimulation intervention We used hs-CRP and IL-6 levels in serum after 20 times treatments with LIPUS as the primary outcome measures Serum myocardial injury indicators levels and blood lipids indicators levels markers of endothelial function levels inflammatory factor levels hemodynamic Indicators Echocardiogram 6-minute walk test Short-term Heart rate variability and mental health assessment were secondary outcomes The researchers tested the outcome indicators at baseline 24th hours after PCI 5th and 10th days and 1st and 3rd months after the intervention Statistical analyses were performed using SPSS 260 statistical software
Discussion This study is the first clinical study of the rehabilitation efficacy of cardiovascular ultrasound in the treatment of coronary heart disease after PCI Given that the current clinical recovery mainly depends on the bodys self-limiting and conventional symptomatic treatment Cardiovascular ultrasound as a new therapy method might be a major advance in the treatment of coronary heart disease after PCI
Methods and design This is a prospective parallel-group randomized control trial We will enroll 200 patients with coronary artery disease after PCI and randomize them into 2 groups The intervention group was given usual practice combined with cardiovascular ultrasound intervention and the control group was given usual practice combined with empty stimulation intervention We used hs-CRP and IL-6 levels in serum after 20 times treatments with LIPUS as the primary outcome measures Serum myocardial injury indicators levels and blood lipids indicators levels markers of endothelial function levels inflammatory factor levels hemodynamic Indicators Echocardiogram 6-minute walk test Short-term Heart rate variability and mental health assessment were secondary outcomes The researchers tested the outcome indicators at baseline 24th hours after PCI 5th and 10th days and 1st and 3rd months after the intervention Statistical analyses were performed using SPSS 260 statistical software
Discussion This study is the first clinical study of the rehabilitation efficacy of cardiovascular ultrasound in the treatment of coronary heart disease after PCI Given that the current clinical recovery mainly depends on the bodys self-limiting and conventional symptomatic treatment Cardiovascular ultrasound as a new therapy method might be a major advance in the treatment of coronary heart disease after PCI
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