Pregnancy Related Inappropriate Sinus Tachycardia Syndrome Study
| Registry | NCT03317249, acronym PRIST |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 200 (Estimated) |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (Other) |
| Conditions | Inappropriate Sinus Tachycardia, Pregnancy Related |
| Interventions | ECG, heart rate monitor, Autonomic Nervous System (ANS) Activity, Haemodynamic variables, Echocardiogram (Diagnostic test, other) |
| Dates | start 2017-10-06, primary completion 2020-10-06 (estimated), completion 2020-10-06 (estimated), first posted 2017-10-23, last updated 2019-01-22 |
| Locations | 1 site in United Kingdom |
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A feasibility study into the exploration of possible mechanisms underlying inappropriate sinus tachycardia (IST) syndrome in pregnancy.
This is a non-interventional, physiological study which will explore the feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia, with the aim of providing scope for future research.
Sinus tachycardia (normal heart rhythm but fast heart rate) is common and usually related to an obvious cause (e.g. exercise such a running or cycling) and doesn't cause any untoward symptoms. In rare cases however, sinus tachycardia can occur without an obvious cause (i.e. it is inappropriate to the situation) and can cause distressing symptoms such as palpitations, dizziness and breathlessness at rest or with minimal exertion. This syndrome of inappropriate sinus tachycardia is poorly understood and can be difficult to manage; especially when the affected individual is pregnant. In order to understand the condition better and improve care pathways we aim to measure various features of the cardiovascular system in pregnant women with and without IST.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Pregnant Healthy | Diagnostic Test: ECG; Diagnostic Test: heart rate monitor; Diagnostic Test: Autonomic Nervous System (ANS) Activity; Diagnostic Test: Haemodynamic variables; Other: Echocardiogram | Pregnant females aged between 18-45 years who do not have IST syndrome | |
| Pregnant IST | Diagnostic Test: ECG; Diagnostic Test: heart rate monitor; Diagnostic Test: Autonomic Nervous System (ANS) Activity; Diagnostic Test: Haemodynamic variables | Pregnant females aged between 18-45 years who have IST syndrome |
Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: * Aged 18-45 years of age * Able to give written informed consent and willing to participate * The participant falls into one of the below categories: i. Pregnant women with IST ii. Pregnant women without IST Exclusion Criteria: * Obesity (BMI > 29.9) * Current or recent (within last 3 months) smoker * Known medical condition likely to affect HRV (other than IST in relevant groups) * Previous history of hypertensive disorders in pregnancy * Lack of written informed consent
| Facility | City | Country | Status |
|---|---|---|---|
| Addenbrookes Hospital | Cambridge | United Kingdom | Recruiting |