Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04649463
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2020-11-21
Brief Title:
Ambulatory Blood Pressure Monitoring in Patients With Coronary Artery Disease
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Ambulatory Blood Pressure Monitoring Optimizes Blood Pressure Control in Patients With Coronary Artery Disease-a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-11
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:
PCI-BP
Brief Summary:
Background Office blood pressure OBP is used for diagnosing and treating hypertension but ambulatory blood pressure measurement ABPM associates more accurately with patient outcome The optimal blood pressure in patients with coronary artery disease CAD is still unknown Our objective was to investigate whether physician awareness of ABP after percutaneous coronary intervention PCI improved BP-control Methods A total of 201 patients performed ABPM before and after their PCI follow-up visit Patients were randomized to open O or concealed C ABPM results for the physician at the follow-up visit The change in ABP and antihypertensive medication in relation to baseline ABP was compared between the two groups
Detailed Description:
Study design and patient population We included 225 patients scheduled for follow up after an acute or elective percutaneous coronary intervention PCI at the Department of Cardiology at the Karolinska University Hospital 2009-2015 Exclusion criteria were age 18 or 90 years Information on medical history date and indication for PCI were collected from the medical records by the study physician OH
All patients were subject to ABPM at baseline 3-6 weeks after PCI and follow up 11-18 weeks after PCI At the time of the first ABPM the patients also completed a questionnaire about smoking habits and current antihypertensive drug treatment Weight kg and height cm was measured At the clinical follow up visit one to two weeks later they were assessed by a cardiologist not involved in the study At this visit ABPM results were either used or not according to randomization in the decision making for adjustments in antihypertensive medication The cardiologists were provided with reference values for ABPM according to guidelines2627 For those with concealed ABPM-results the OBP was used for decision making regarding changes in antihypertensive treatment Finally results regarding BP control were assessed at the second ABPM 8-12 weeks following the first measurement
Office Blood pressure measurement OBP was recorded in both arms by a biomedical scientist or a specialized nurse study staff using a mercury sphygmomanometer with the subject in the supine position after 5 min of rest The mean of two consecutive readings was calculated If there was a difference in systolic or diastolic BP SBP DBP between the arms of 10 mmHg the arm with the highest reading was used when defining OBP otherwise the non-dominant arm was used The same arm was used at the follow up where either the physician or a nurse measured OBP after having been given instructions for standardized BP measurement as described above
Ambulatory BP Ambulatory BP values were obtained using a noninvasive oscillometric system Spacelabs 90217 Spacelabs Healthcare Hertford UK The device was fitted to the patient by one of the study staff Patients were instructed not to restrict their daily activities during the monitoring periods Before the start of the monitoring period the automatic readings were cross-checked against manually measured BP by auscultation The device was fitted to the nondominant arm unless a difference of 10 mmHg in SBP between the arms was recorded in which case the arm with the highest pressure was used BP and heart rate were recorded automatically every 20 minutes daytime and every hour at night for a 24-h period The BP data was auto-edited by the Spacelabs program which excluded presumably erroneous data No manual editing of data was carried out in order not to induce bias Means were calculated for the whole 24-h period and for day 0700-2100 and night 2400-0600 periods separately
Antihypertensive drug treatment The agents according to guidelines26 27 classified as BP lowering were thiazide- and potassium saving diuretics beta-blockers calcium antagonists ACE inhibitors angiotensin II receptor blockers and others doxazocin only one used At the follow up antihypertensive treatment changes were reported by the physician in the study protocol The patients current antihypertensive treatment was also documented prior to the 2nd ABPM by the study staff All antihypertensive treatment was further recorded as a percentage of recommended maximal daily doses to allow for calculation of treatment change The latter was calculated as the difference in antihypertensive treatment between prior to the physician follow up and ongoing medication at the 2nd ABPM
Statistical analysis Mean and standard deviation SD were used for numerical data whereas median and range was used for the number of days until follow-up visit and the number of BP-lowering agents Chi-square-tests or Fishers exact test were used to compare ratios between groups where the variables were nominal Independent t-tests were used to compare continuous variables between groups since the variables investigated were normally distributed In order to study whether the intervention optimized BP across the distribution of baseline ABP a multivariate analysis was performed and the interactions between study groups on the association between baseline ABP and change in ABP as well as change in antihypertensive therapy was calculated Separate analysis was performed in the diabetic subgroup A p-value 005 were used to define statistical significance Statistical analysis was done in the StatSoft program STATISTICA
Ethical considerations Ethical approval was applied for and approved by the Stockholm Regional Ethical Review Board reference number 20081017-31 All subjects gave informed consent
All patients were subject to ABPM at baseline 3-6 weeks after PCI and follow up 11-18 weeks after PCI At the time of the first ABPM the patients also completed a questionnaire about smoking habits and current antihypertensive drug treatment Weight kg and height cm was measured At the clinical follow up visit one to two weeks later they were assessed by a cardiologist not involved in the study At this visit ABPM results were either used or not according to randomization in the decision making for adjustments in antihypertensive medication The cardiologists were provided with reference values for ABPM according to guidelines2627 For those with concealed ABPM-results the OBP was used for decision making regarding changes in antihypertensive treatment Finally results regarding BP control were assessed at the second ABPM 8-12 weeks following the first measurement
Office Blood pressure measurement OBP was recorded in both arms by a biomedical scientist or a specialized nurse study staff using a mercury sphygmomanometer with the subject in the supine position after 5 min of rest The mean of two consecutive readings was calculated If there was a difference in systolic or diastolic BP SBP DBP between the arms of 10 mmHg the arm with the highest reading was used when defining OBP otherwise the non-dominant arm was used The same arm was used at the follow up where either the physician or a nurse measured OBP after having been given instructions for standardized BP measurement as described above
Ambulatory BP Ambulatory BP values were obtained using a noninvasive oscillometric system Spacelabs 90217 Spacelabs Healthcare Hertford UK The device was fitted to the patient by one of the study staff Patients were instructed not to restrict their daily activities during the monitoring periods Before the start of the monitoring period the automatic readings were cross-checked against manually measured BP by auscultation The device was fitted to the nondominant arm unless a difference of 10 mmHg in SBP between the arms was recorded in which case the arm with the highest pressure was used BP and heart rate were recorded automatically every 20 minutes daytime and every hour at night for a 24-h period The BP data was auto-edited by the Spacelabs program which excluded presumably erroneous data No manual editing of data was carried out in order not to induce bias Means were calculated for the whole 24-h period and for day 0700-2100 and night 2400-0600 periods separately
Antihypertensive drug treatment The agents according to guidelines26 27 classified as BP lowering were thiazide- and potassium saving diuretics beta-blockers calcium antagonists ACE inhibitors angiotensin II receptor blockers and others doxazocin only one used At the follow up antihypertensive treatment changes were reported by the physician in the study protocol The patients current antihypertensive treatment was also documented prior to the 2nd ABPM by the study staff All antihypertensive treatment was further recorded as a percentage of recommended maximal daily doses to allow for calculation of treatment change The latter was calculated as the difference in antihypertensive treatment between prior to the physician follow up and ongoing medication at the 2nd ABPM
Statistical analysis Mean and standard deviation SD were used for numerical data whereas median and range was used for the number of days until follow-up visit and the number of BP-lowering agents Chi-square-tests or Fishers exact test were used to compare ratios between groups where the variables were nominal Independent t-tests were used to compare continuous variables between groups since the variables investigated were normally distributed In order to study whether the intervention optimized BP across the distribution of baseline ABP a multivariate analysis was performed and the interactions between study groups on the association between baseline ABP and change in ABP as well as change in antihypertensive therapy was calculated Separate analysis was performed in the diabetic subgroup A p-value 005 were used to define statistical significance Statistical analysis was done in the StatSoft program STATISTICA
Ethical considerations Ethical approval was applied for and approved by the Stockholm Regional Ethical Review Board reference number 20081017-31 All subjects gave informed consent
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