NCT03317249|Unknown
Pregnancy Related Inappropriate Sinus Tachycardia
PRIST
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PRIST
Sponsor study identifier
observational
200
1 country
1
Study Start
October 6, 2017
Actual (reported)Primary Completion
October 6, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 6, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A feasibility study into the exploration of possible mechanisms underlying inappropriate sinus tachycardia (IST) syndrome in pregnancy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 6, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 6, 2017
Actual (reported)October 6, 2017
Actual (reported)October 23, 2017
Actual (reported)October 6, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 6, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia
Number of women in each group who agree to participate in the study
Up to 3 years
Assessment of autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia
Heart rate variability (HRV) at rest using time and frequency domain (e.g. SDNN ms and LF and HF), combined to give absolute power in ms².
Up to 3 years
Assessment of autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia
Baroreflex sensitivity (BRS) at rest calculated from the change in systolic pressure and change in R-R interval to give change in pressure per change in RR interval, measured in milliseconds (mmHg/ms)
Up to 3 years
Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
Up to 3 years
Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
Up to 3 years
Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
Up to 3 years
Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
Up to 3 years
Pregnant females aged between 18-45 years who do not have IST syndrome
Pregnant females aged between 18-45 years who have IST syndrome
12-lead electrocardiogram
24-hour heart rate monitor used to calculate mean heart rate and heart rate variability
Hospital clinics (cardiology clinics and antenatal clinics)
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Mark Belham
Cambridge University Hospitals NHS Foundation Trust
First Submitted
October 6, 2017
First Posted
October 23, 2017
Study Start
October 6, 2017
Actual (reported)Primary Completion
October 6, 2020
Estimated (date passed)Home Pregnancy Test Study on BioBank Samples
Heart Rate Variability (HRV) and Baroreflex sensitivity (BRS): Resting and exercise HRV and BRS calculated from ECG, Dundee Step test and blood pressure measurements.
Cardiac output (CO), stroke volume (SV) and systematic vascular resistance (SVR) will be assessed and calculated using a non-invasive, inert gas re-breathing technique whereby expired gases will be sampled and analysed alongside and blood pressure measurements.
optional (for non-IST participants only)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 6, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 22, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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