Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644872
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
The Effect of Short-term Bed Rest on Cardiac Function Measured by Cardiac Magnetic Resonance Imaging
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Short-term Bed Rest on Cardiac Function Measured by Cardiac Magnetic Resonance Imaging
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
MRtime
Brief Summary:
The primary objective of this study is to investigate the effect of short-term bed rest 4 hours on heart function measured by cardiac magnetic resonance CMR in healthy participants This aim will be addressed through a single-arm repeated study assessing participants during three hours of bedrest
The hypothesis is that short-term bed rest will decrease cardiac output measured by repeated CMR scans
This study will also investigate the reproducibility of CMR within a narrow time frame Limited data are available on these aspects despite their critical importance for conducting consecutive examinations both in clinical practice and research trials10-12 The study also aims to investigate the appliances of short-time measures of cardiac function
The hypothesis is that short-term bed rest will decrease cardiac output measured by repeated CMR scans
This study will also investigate the reproducibility of CMR within a narrow time frame Limited data are available on these aspects despite their critical importance for conducting consecutive examinations both in clinical practice and research trials10-12 The study also aims to investigate the appliances of short-time measures of cardiac function
Detailed Description:
The study will be conducted as a single-arm repeated measurement study in healthy participants n19 The participants will undergo a three and half-hour experimental day
Initially potential participants are invited to an information meeting and after informed consent a control screening of MR contraindications is fulfilled Following inclusion the test day are conducted The participants will arrive after a 4-hour period with no intake of food and drinks except 250g of water and by passive transportation train bus or car After arrival a vein catheter is inserted into the antecubital vein Then a basal venous blood sample -15 min is drawn 4 ml in total for analysis of plasma catecholamine and acetylcholine and blood pressure is taken Thereafter the first basal CMRs will be performed with ECG monitoring
During the test day the participants will undergo five 15 min CMR imaging scans at 0 30 60 120 and 180 mins The first three are consecutive measurements with short breaks between therefor the participants will lay in the scanner for the first 75 min and stay in bed in between the two sequential measurements The participants will be in bedrest throughout the experimental day Venous blood samples 4 ml are obtained at 75 110 and 170 min where also blood pressure is taken In total up to 25 ml blood is obtained during the test day The duration of the test day is 45 hour
The time requirements for each participant are summarized
Information meeting and screening approximately 15 hour
1 test day of approximately 45 hour
Screening At the screening height and body weight will be measured and a questionnaire on contraindications for CMR will be completed to ensure compliance to the scanner The daily study leader will ask about previous illnesses medication intake alcohol and smoking habits
Statistical considerations Measures of myocardial function are highly reproducible when assessed using CMR and interstudy and cohort coefficients of variation are in the range of 3-510-12 In this study the primary outcome is change in cardiac output after bed rest compared with the first CMR scanning before bed rest
In an ongoing study preliminary observations reveal a decrease of meanSD -109 in CO and -4159 in LVEF in both healthy participants and those with heart failure after two hours of bed rest as evaluated by CMR
For the upcoming study the aim is to be able to detect a minimal effect difference of 10 and variation in the CMR data sampling as evident from unpublished observations described above Sample size calculations were performed considering a conservative approach with a power of 95 and a significance level of 005 utilizing paired Students t-test for data evaluation The calculations are as follows
For changes in CO 11 participants would be sufficient to detect a 10 change
For changes in LVEF 19 participants would be adequate to detect a 4 change To account for potential dropouts or failed scans the plan is to include up to 29 participants until 19 completed experimental days have been obtained
In regard to the analysis plan a t-test comparing the first no bedrest and the last CMR scan 4h bed rest is the primary endpoint further a mixed model will be performed to assess the difference in cardiac function throughout the day
Participants Participants in this study consist of 19 healthy male and female participants
Initially potential participants are invited to an information meeting and after informed consent a control screening of MR contraindications is fulfilled Following inclusion the test day are conducted The participants will arrive after a 4-hour period with no intake of food and drinks except 250g of water and by passive transportation train bus or car After arrival a vein catheter is inserted into the antecubital vein Then a basal venous blood sample -15 min is drawn 4 ml in total for analysis of plasma catecholamine and acetylcholine and blood pressure is taken Thereafter the first basal CMRs will be performed with ECG monitoring
During the test day the participants will undergo five 15 min CMR imaging scans at 0 30 60 120 and 180 mins The first three are consecutive measurements with short breaks between therefor the participants will lay in the scanner for the first 75 min and stay in bed in between the two sequential measurements The participants will be in bedrest throughout the experimental day Venous blood samples 4 ml are obtained at 75 110 and 170 min where also blood pressure is taken In total up to 25 ml blood is obtained during the test day The duration of the test day is 45 hour
The time requirements for each participant are summarized
Information meeting and screening approximately 15 hour
1 test day of approximately 45 hour
Screening At the screening height and body weight will be measured and a questionnaire on contraindications for CMR will be completed to ensure compliance to the scanner The daily study leader will ask about previous illnesses medication intake alcohol and smoking habits
Statistical considerations Measures of myocardial function are highly reproducible when assessed using CMR and interstudy and cohort coefficients of variation are in the range of 3-510-12 In this study the primary outcome is change in cardiac output after bed rest compared with the first CMR scanning before bed rest
In an ongoing study preliminary observations reveal a decrease of meanSD -109 in CO and -4159 in LVEF in both healthy participants and those with heart failure after two hours of bed rest as evaluated by CMR
For the upcoming study the aim is to be able to detect a minimal effect difference of 10 and variation in the CMR data sampling as evident from unpublished observations described above Sample size calculations were performed considering a conservative approach with a power of 95 and a significance level of 005 utilizing paired Students t-test for data evaluation The calculations are as follows
For changes in CO 11 participants would be sufficient to detect a 10 change
For changes in LVEF 19 participants would be adequate to detect a 4 change To account for potential dropouts or failed scans the plan is to include up to 29 participants until 19 completed experimental days have been obtained
In regard to the analysis plan a t-test comparing the first no bedrest and the last CMR scan 4h bed rest is the primary endpoint further a mixed model will be performed to assess the difference in cardiac function throughout the day
Participants Participants in this study consist of 19 healthy male and female participants
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