Ignite Creation Date:
2024-05-06 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03566654
Status:
UNKNOWN
Last Update Posted:
2019-09-13
First Post:
2018-03-27
Brief Title:
Clinical Trial on Remote Ischemic Conditioning and HypertensionHOPE
Sponsor:
Ji XunmingMDPhD
Organization:
Capital Medical University
Study Overview
Official Title:
A Random Controlled Double-Blind Clinical Trial Remote Ischemic Conditioning and Hypertension
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
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:
Nowadays the incidence of stroke in China has reached 16 and this disease has became a primary cause of death in China One of its major risk factors is hypertension As shown in the researches the risk of stroke grows remarkably when the blood pressure increases and there exists a log-linear relationship between them Systolic pressure and diastolic pressure relate to the risk of stroke independently Systolic pressure decreasing 10mmHg will reduce the stroke risk by 31 and decrease of 13mmHg will reduce the stroke risk by 2030 As to diastolic pressure 5mmHg decrease of it will reduce the stroke risk by 34 and 10mmHg decrease of it will reduce the stroke risk by 56 In addition patients with isolated systolic hypertension SPB160mmHg DPB90mmHg or critical isolated systolic hypertension SPB140159mmHg DPB 90mmHg will suffer a higher risk of stroke than people with normal blood pressure The ACC has already revised its Hypertension Management Guidelines of standard of diagnosis for hypertension and timing of starting medical treatment in hypertensive patientsBecause more and more reseaches shown that people with blood pressure between 120-13980-89mmHg have higher risk of ASCVSD compared to those with blood pressure lower than 12080mmHg However in China the diagnostic criteria for hypertension has not been revised yet Therefore we still have blind spot in treating such patients who suffer from borderline systolic hypertension at 130140 mmHg of blood pressure with or without ASCVD or those with the first stage hypertension but refusing to take anti-hypertension drugs What is more most of them are middle-aged adults once they have stroke it would lead terrible and costly consequences to both their family and the society Thus it is necessary to explore new non-pharmacological methods to control blood pressure for reducing the risk of stroke
Detailed Description:
There already have had some researchers found the phenomenon of lowing blood pressure among heart failure patients and pre-hypertensive individuals after a long-term of ischemic conditioning therapy However theres still lack of specific clinical trials carried out to confirm itspotential treatment effect of lowing blood pressure
The investigators designed this randomized doubleblind controlled clinical trial to examine 1 whether RIC has a beneficial effect on blood pressure 2 whether RIC exert its protection effect through immunological regulation There are 2 arms in this trial One arm is RIC treatment the other one is sham RIC treatment Blood pressure will be measured by ambulatory blood pressure monitoring before and after the treatment to evaluate its exact effect on BP Also circulatory immunological factors will be tested before and after the treatment to illustate whether immunological regulation involved in the process
The investigators designed this randomized doubleblind controlled clinical trial to examine 1 whether RIC has a beneficial effect on blood pressure 2 whether RIC exert its protection effect through immunological regulation There are 2 arms in this trial One arm is RIC treatment the other one is sham RIC treatment Blood pressure will be measured by ambulatory blood pressure monitoring before and after the treatment to evaluate its exact effect on BP Also circulatory immunological factors will be tested before and after the treatment to illustate whether immunological regulation involved in the process
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