N/A
N=47
The Effects of Menstrual Cycle Phase on Exercise Treadmill Test Results in Premenopausal Women
Menstrual Cycle · Exercise Treadmill
Bottom Line
View on ClinicalTrials.gov: NCT05985980 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: ST/HR Index (μV/Bpm) — 1.2; 1.3 μV/Bpm — p=0.521
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Exercise Treadmill Test (ETT) (Diagnostic_test)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Istanbul Medeniyet University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ST/HR Index (μV/Bpm) |
1.2; 1.3 | 0.521 |
| SECONDARY High-sensitive Cardiac Troponin T (ng/L) After ETT |
3.3; 3.6; 3.6; 3.6 | 0.109 |
| SECONDARY Maximal Exercise Capacity (METs Score) |
10.0; 10.5 | 0.111 |
| SECONDARY ST/HR Slope (μV/Bpm) |
1.8; 1.7 | 0.414 |
| SECONDARY Maximal Horizontal or Down Slope ST Segment Depression (mm) During Exercise Treadmill Test |
0.13; 0.15 | 0.062 |
| SECONDARY Estrogen Levels Before the Exercise Treadmill Test. |
33.3; 105.0 | <0.001 sig |
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. Primary purpose of the study is to investigate the biological causes of false positive test results in the ETT in premenopausal women. Estrogen is known to have direct vasodilatory effects on coronary arteries. The early and late follicular phases of the menstrual cycle are characterized by low and high estrogen levels, respectively. The early follicular phase starts on the first day of the menstrual cycle and ends when estrogen begins to increase. It is characterised by increasing luteinizing hormone (LH) and follicle stimulating hormone (FSH) and low estrogen levels. The estrogen levels increase several folds in the late follicular phase. The hypothesis of the study is that ETT results will change at the early and late follicular phases of the menstrual cycle in premenstrual women. Premenopausal women between the ages of 20-55 years, who apply to the cardiology outpatient clinics of Göztepe City Hospital with chest pain. Patients who are ordered to have an ETT will be included in the study. ETT will be performed separately during the early and late follicular phases of the menstrual cycle.
The major finding of Exercise Treadmill Test is the ST segment deviation from the baseline. The ST segments are evaluated 60-80 ms after the J point. ECG positive Exercise Treadmill Test result was defined as ≥ 1 mm (0.1 mV) horizontal or downsloping ST depression in at least 3 consecutive beats.
Chest pain or inadequate hemodynamic response during Exercise Treadmill Tests are considered clinically positive Exercise Treadmill Test result. Tests that do not meet these criteria but show ST segment changes or had low diagnostic value due to baseline ECG changes are considered indeterminate Exercise Treadmill Test results.
Automated measurements and mathematical calculations are recorded in the Exercise Treadmill Test system (General Electronic GE Healthcare T2100-ST Treadmill & CASE 6.73 Stress Test System). ST/HR index during Exercise Treadmill Tests at the early and late follicular phases of the menstrual cycle (µV/beats per minute (bpm)) will be compared in all patients. The secondary endpoints were ST/HR slope, maximum ST segment depression (mm), maximum exercise capacity, and the change in estrogen levels between the early and late follicular phases of the menstrual cycle. The study will also compare the concentrations of hs-cTnT before and after Exercise Treadmill Test. Exercise Treadmill Test results are evaluated by 2 different cardiologists and categorized as positive/indeterminate/negative Exercise Treadmill Test results. The concentrations of Hs-cTn are measured before and 15 minutes after Exercise Treadmill Test.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05985980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.