The Effects of Menstrual Cycle Phase on Exercise Treadmill Test Results in Premenopausal Women

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.

Conditions

• Menstrual Cycle
• Exercise Treadmill

Interventions

DIAGNOSTIC_TEST

Exercise Treadmill Test (ETT)

The study population consists of premenopausal women who applied to the outpatient clinic with chest pain. ETT is ordered as a routine diagnostic workup. Two ETTs are performed on each participant. The early follicular phase ETT is planned on the 3rd day of menstrual bleeding, while the menstrual bleeding continues. The late follicular phase ETT is planned on the 3rd day after the menstrual bleeding ends. Hormone levels are measured before each ETT to ascertain the phase of the menstrual cycle.

Sponsors & Collaborators

• Istanbul Medeniyet University

  lead OTHER

Principal Investigators

• Sukru Sadık Öner, MD PhD · Istanbul Medeniyet University City Hospital Goztepe

Eligibility

Min Age

20 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2023-09-11

Completion

2023-09-12

Countries

• Turkey (Türkiye)

Study Locations