The influence of the menstrual cycle on diagnostic results of cardiovascular diseases - The Cycle Study II

Recruiting

• Conditions: Cardiovascular disease; 10082206; 10007510

• Registration Number: NL-OMON48937
• Lead Sponsor: Vasculaire geneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 324

Inclusion Criteria

- 18 years or older
- Regular menstrual cycle
- Cardiac complaints or diagnosed Familial Hypercholesterolemia
- Treated by a cardiologist/GP for their complaints

Exclusion Criteria

- <18 years of age
- Postmenopausal
- Use of contraception that affects the menstrual cycle (except for the oral
contraceptive pill with monthly stopping)
- Underwent ovariectomy
- Pregnant
- Otherwise does not have a regular menstrual cycle
- Unable to give informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In the patients presenting with palpitations, the incidence of cardiac<br /><br>arrhythmias is the main study parameter.<br /><br><br /><br>In the patients presenting with chest pain, the time to ST depression during<br /><br>symptom limited exercise testing is the main study parameter.<br /><br><br /><br>In the FH patients, lipid levels (TC, LDL-C, HDL-C, TG, apoB and Lp(a)) are the<br /><br>main study parameter.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In the patients presenting with palpitations, the incidence of symptomatic vs.<br /><br>silence arrhythmias is the secondary endpoint.<br /><br><br /><br>In the patients presenting with chest pain that do not show ST depressions<br /><br>during symptom limited exercise testing, the subjective experience of chest<br /><br>pain is the secondary endpoint.</p><br>