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

NCT05985980 | Completed Results

• 1 other identifier: 2023/0129
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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. 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

Outcome Measures

Primary Outcomes (1)

• ST/HR Index (μV/Bpm)

  The ST/HR index (μV/bpm) is automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill \& CASE 6.73 Stress Test System at the end of the exercise treadmill test (ETT).

  approximately 15 minutes each during the exercise treadmill tests performed at the early and late follicular phases of the menstrual cycle

Secondary Outcomes (5)

• High-sensitive Cardiac Troponin T (ng/L) After ETT

  approximately 1 hour each during the exercise treadmill tests performed at the early and late follicular phase of the menstrual cycle

• Maximal Exercise Capacity (METs Score)

  approximately 15 minutes each during the exercise treadmill tests performed at the early and late follicular phases of the menstrual cycle

• ST/HR Slope (μV/Bpm)

  approximately 15 minutes each during the exercise treadmill tests performed at the early and late follicular phases of the menstrual cycle

• Maximal Horizontal or Down Slope ST Segment Depression (mm) During Exercise Treadmill Test

  approximately 15 minutes each during the exercise treadmill tests performed at the early and late follicular phases of the menstrual cycle

• Estrogen Levels Before the Exercise Treadmill Test.

  approximately 1 hour before the exercise treadmill tests performed at the early and late follicular phases of the menstrual cycle

Study Arms (1)

Exercise Treadmill Tests at the early and late follicular phases in premenopausal women

The study population consists of premenopausal women who applied to the outpatient clinic with chest pain between February 2023 and July 2023. Exercise Treadmill Tests are planned as part of the routine clinical workup. The history of the patient's menstrual cycle is obtained in detail. The early and late follicular phases are determined from the history. Two separate Exercise Treadmill Tests are performed on each patient. The early follicular phase Exercise Treadmill Test is planned on the 3rd day of menstrual bleeding, while the menstrual bleeding continues. The late follicular phase Exercise Treadmill Test is planned on the 3rd day after the menstrual bleeding ends. Hormone levels are measured before each Exercise Treadmill Test to ascertain the phase of the menstrual cycle.

Diagnostic Test: Exercise Treadmill Test (ETT)

Interventions

Exercise Treadmill Test (ETT) DIAGNOSTIC_TEST

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.

Exercise Treadmill Tests at the early and late follicular phases in premenopausal women

Eligibility Criteria

• Age: 20 Years - 55 Years
• Gender Eligibility Details: Female patients in the pre-menopausal period
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University Hospital, Goztepe

Istanbul, 34722, Turkey (Türkiye)

Location

Related Publications (1)

• Oktay A, Torustag I, Isman FK, Agirbasli M. Effects of Menstrual Cycle on Exercise Treadmill Parameters and Cardiac Troponin Release in Premenstrual Women. Diagnostics (Basel). 2025 Jun 18;15(12):1548. doi: 10.3390/diagnostics15121548.

  PMID: 40564868 BACKGROUND

Results Point of Contact

• Title: Mehmet Agirbasli MD
• Organization: Istanbul Medeniyet University

agirbasli@gmail.com

+902166065200

Study Officials

• Sukru Sadık Öner, MD PhD

  Istanbul Medeniyet University City Hospital Goztepe

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Professor of Cardiology

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 14, 2023
• Study Start: March 1, 2023
• Primary Completion: September 11, 2023
• Study Completion: September 12, 2023
• Last Updated: April 15, 2026
• Results First Posted: November 12, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)