Status:
COMPLETED
The Effects of Menstrual Cycle Phase on Exercise Treadmill Test Results in Premenopausal Women
Lead Sponsor:
Istanbul Medeniyet University
Conditions:
Menstrual Cycle
Exercise Treadmill
Eligibility:
FEMALE
20-55 years
Brief Summary
False positive results are commonly observed in women after exercise treadmill test (ETT). The effects of menstrual cycle on the results of ETT in premenopausal women have not been clearly defined. Pr...
Detailed Description
General Hypothesis: False positive results are commonly observed in women after exercise treadmill test (ETT). The studies report severe variability in the sensitivity and specificity of ETT in detec...
Eligibility Criteria
Inclusion
- The inclusion criteria are:
- Premenopausal female patients with regular menstrual cycles,
- Ages between 20-55 years,
- Patients have been seen in the cardiology clinic by a cardiologist for the symptoms of chest pain with a clinical suspicion of angina or angina equivalent.
- A cardiologist has ordered ETT as a diagnostic test independent of the study protocol
- Patients can understand and sign the informed consent.
- The exclusion criteria are:
- The exclusion criteria are:
- Women with menopause or menopause-related symptoms or menstrual cycle irregularity or use of hormonal therapy or oral contraceptives, current pregnancy
- Patients with a history of CAD, secondary or uncontrolled hypertension, valvular heart disease, cardiac arrhythmia or heart failure, pericarditis or myocarditis.
- Left ventricular hypertrophy on echocardiography, abnormal systolic or diastolic function or wall motion abnormality on echocardiography.
- History of cancer, stage ≥ 3 kidney failure, liver failure, history of psychiatric illness, history of recent infection.
- Pre-existing ECG abnormality that would confound the interpretation during the ETT (baseline ECG was considered abnormal ın the presence of the following findings: prolonged QT interval, chamber hypertrophy, alterations in the ST-T waves, any degree of heart block, T-wave abnormalities, premature ventricular contractions (PVCs), right bundle branch block (RBBB), left bundle branch block (LBBB), left or right axis deviation, or any abnormal rhythm other than normal sinus rhythm).
- Patients who cannot tolerate Bruce protocol in the first ETT.
- Lack of ability or mental capacity to understand the study.
Exclusion
Key Trial Info
Start Date :
March 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 12 2023
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT05985980
Start Date
March 1 2023
End Date
September 12 2023
Last Update
November 12 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Istanbul Medeniyet University Hospital, Goztepe
Istanbul, Turkey (Türkiye), 34722