Trial Outcomes & Findings for The Effects of Menstrual Cycle Phase on Exercise Treadmill Test Results in Premenopausal Women (NCT NCT05985980)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

47 participants

Primary outcome timeframe

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

Results posted on

2024-11-12

Participant Flow

Repeated exercise treadmill tests (ETT) are performed by using the standard Bruce protocol, during early and late follicular phases of menstrual cycle.

Participant milestones

Participant milestones
Measure	All Study Participants Undergo 2 Consecutive Exercise Treadmill Tests (ETT) Exercise treadmill test (ETT) is performed at the early and late follicular phase of the menstrual cycle.
Overall Study STARTED	47
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Undergo 2 Consecutive Exercise Treadmill Tests (ETT) Exercise treadmill test (ETT) is performed at the early and late follicular phase of the menstrual cycle.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Test Results Are Performed at the Early and Late Follicular Phases of Menstrual Cycle. n=43 Participants The study population consists of premenopausal women who applied to the outpatient clinic with chest pain between February 2023 and July 2023. Patients report that they have a regular menstrual cycle. Written informed consent is obtained from the patients. All patients have transthoracic echocardiography. Echocardiography demonstrates normal left ventricular systolic and diastolic function. Echocardiography does not show wall motion abnormality or significant valvular heart disease. All patients are evaluated for cardiovascular risk. The history of the menstrual cycle of the patient is obtained in detail. The early and late follicular phases are determined from the history. 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. Two ETTs are performed on each participant. The duration and regularity of the menstrual cycle, the amount of bleeding, and the number of days the bleeding lasted are noted for each patient. Patients with irregular menstrual cycles, breakthrough bleeding, spotting, gynecological examination, or treatment plan that would disrupt the menstrual cycle are excluded from the study. The exercise treadmill tests are performed at early and late follicular phases of menstrual cycle for every participant of the study.
Age, Categorical <=18 years	0 Participants n=43 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=43 Participants
Age, Categorical >=65 years	0 Participants n=43 Participants
Age, Continuous	38 years STANDARD_DEVIATION 7 • n=43 Participants
Sex: Female, Male Female	43 Participants n=43 Participants
Sex: Female, Male Male	0 Participants n=43 Participants
Region of Enrollment Turkey	43 Participants n=43 Participants
Premenopausal women with chest pain who are ordered to have ETT as part of routine care.	43 Participants n=43 Participants

PRIMARY outcome

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

Population: ST/HR index (μV/bpm) are compared between the ETTs performed at the early and late follicular phases of menstrual cycle.

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).

Outcome measures

Outcome measures
Measure	Early Follicular Phase n=43 Participants Exercise treadmill tests (ETT) are performed at the early follicular phase of menstrual cycle.	Late Follicular Phase ETT n=43 Participants Exercise treadmill tests (ETT) are performed at the late follicular phase of menstrual cycle.
ST/HR Index (μV/Bpm)	1.2 μV/Bpm Standard Deviation 0.82	1.3 μV/Bpm Standard Deviation 0.59

SECONDARY outcome

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

Population: High-sensitive cardiac troponin T (hs-cTnT) levels are compared before and after ETT at the early and late follicular phases of the menstrual cycle.

High-sensitive cardiac troponin T levels (hs-cTnT) are measured by Roche kit before and after the exercise treadmill test both at the early and late follicular phases of the menstrual cycle.

Outcome measures

Outcome measures
Measure	Early Follicular Phase n=43 Participants Exercise treadmill tests (ETT) are performed at the early follicular phase of menstrual cycle.	Late Follicular Phase ETT n=43 Participants Exercise treadmill tests (ETT) are performed at the late follicular phase of menstrual cycle.
High-sensitive Cardiac Troponin T (ng/L) After ETT Hs-cTnT before ETT	3.3 nanogram/liter Standard Deviation 1.1	3.6 nanogram/liter Standard Deviation 1.4
High-sensitive Cardiac Troponin T (ng/L) After ETT Hs-cTnT after ETT	3.6 nanogram/liter Standard Deviation 1.4	3.6 nanogram/liter Standard Deviation 2.5

SECONDARY outcome

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

Population: ETTs are performed at the early and late follicular phases of the menstrual cycle in premenopausal women.

The maximal exercise capacity (METs score) 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).

Outcome measures

Outcome measures
Measure	Early Follicular Phase n=43 Participants Exercise treadmill tests (ETT) are performed at the early follicular phase of menstrual cycle.	Late Follicular Phase ETT n=43 Participants Exercise treadmill tests (ETT) are performed at the late follicular phase of menstrual cycle.
Maximal Exercise Capacity (METs Score)	10.0 METS Standard Deviation 1.9	10.5 METS Standard Deviation 1.2

SECONDARY outcome

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

Population: ETTs are performed at the early and late follicular phases of the menstrual cycle in premenopausal women.

ST/HR slope (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).

Outcome measures

Outcome measures
Measure	Early Follicular Phase n=43 Participants Exercise treadmill tests (ETT) are performed at the early follicular phase of menstrual cycle.	Late Follicular Phase ETT n=43 Participants Exercise treadmill tests (ETT) are performed at the late follicular phase of menstrual cycle.
ST/HR Slope (μV/Bpm)	1.8 μV/Bpm Standard Deviation 1.2	1.7 μV/Bpm Standard Deviation 0.5

SECONDARY outcome

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

Population: Exercise treadmill tests are performed separately during the menstrual cycle's early and late follicular phases.

Maximal horizontal or down slope ST segment depression (mm) 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).

Outcome measures

Outcome measures
Measure	Early Follicular Phase n=43 Participants Exercise treadmill tests (ETT) are performed at the early follicular phase of menstrual cycle.	Late Follicular Phase ETT n=43 Participants Exercise treadmill tests (ETT) are performed at the late follicular phase of menstrual cycle.
Maximal Horizontal or Down Slope ST Segment Depression (mm) During Exercise Treadmill Test	0.13 milimeter Standard Deviation 0.08	0.15 milimeter Standard Deviation 0.08

SECONDARY outcome

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

Population: Estrogen levels before the ETT at the early and late follicular phases.

Estrogen levels are measured 1 hour before the exercise treadmill test (ETT) at the early and late follicular phases of the menstrual cycle.

Outcome measures

Outcome measures
Measure	Early Follicular Phase n=43 Participants Exercise treadmill tests (ETT) are performed at the early follicular phase of menstrual cycle.	Late Follicular Phase ETT n=43 Participants Exercise treadmill tests (ETT) are performed at the late follicular phase of menstrual cycle.
Estrogen Levels Before the Exercise Treadmill Test.	33.3 pg/mL Interval 22.3 to 63.3	105.0 pg/mL Interval 64.7 to 209.0

Adverse Events

Exercise Test Results Will be Grouped Based on the Menstrual Cycle.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mehmet Agirbasli MD

Istanbul Medeniyet University

Phone: +902166065200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place