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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48937
Enrollment
324
Registered
2019-04-03
Start date
2019-10-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease

Interventions

1. Patients with palpitations (appendix 1a) Step 1: Arrhythmia diagnostics and symptoms AEM The AEM will be connected to the participating woman at the Vascular Medicine outpatient clinic in the Er

Sponsors

Vasculaire geneeskunde
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: -

Design outcomes

Primary

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

Secondary

MeasureTime frame
In the patients presenting with palpitations, the incidence of symptomatic vs. silence arrhythmias is the secondary endpoint. In the patients presenting with chest pain that do not show ST depressions during symptom limited exercise testing, the subjective experience of chest pain is the secondary endpoint.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)