Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05985980 |
| Other study ID # |
2023/0129 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
October 1, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Istanbul Medeniyet University |
| Contact |
Mehmet Agirbasli, MD |
| Phone |
90(532)7468840 |
| Email |
agirbasli[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
False positive results are commonly observed in women after exercise treadmill test (ETT).
The effects of menstrual periodic changes on the results of exercise treadmill test 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 treadmill exercise
test in premenopausal women. Estrogen is known to have direct vasodilatory effects on
coronary arteries. 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 oestradiol begins to increase. It is characterised
by increasing LH and FSH and constant low levels of oestradiol. The late follicular phase
starts with the increase in oestradiol and ends at its preovulatory peak. The hypothesis of
the study is that ETT results will change at the early and late follicular phases in
premenstrual women. Premenopausal women between the ages of 18-40, who apply to the
cardiology outpatient clinics of Göztepe City Hospital with typical/atypical chest pain, and
an indication for ETT will be included in the study. ETT will be performed in the early and
late follicular phases of the menstrual cycle, separately.
Description:
Estrogen is known to have direct vasodilatory effects on coronary arteries. Early and late
follicular phases of the menstrual cycle in premenopausal women 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 oestradiol begins to increase. It is characterised by
increasing LH and FSH and constant low levels of oestradiol. The late follicular phase starts
with the increase in oestradiol and ends at its preovulatory peak. Premenopausal women
(between the ages of 18-40), who apply to the cardiology outpatient clinics of Göztepe City
Hospital with typical/atypical chest pain, and an indication for exercise treadmill test
(ETT) will be included in the study. ETT will be performed in the early and late follicular
phases of the menstrual cycle, separately.
Forty (40) patients who meet these conditions will be included in the study.
The menstrual cycle of the patient will be questioned in the screening interview.
Premenopausal female patients between the ages of 18-40 who still have a regular menstrual
cycles will be included in the study. Hormone levels including Estradiol III, follicle
stimulating hormone (FSH), luteinizing hormone (LH), progesterone (Elecsys) will be measured
to confirm the menstrual cycle before each ETT. ETT will be performed in the early and late
follicular phases of the menstrual cycle, separately. Cardiac high sensitive troponin I (hs
cTnI) (Roche) will be measured before and after ETT.
Primary end point will the ST/HR (heart rate) index (μV/bpm) in ETT. The ST/HR index (μV/bpm)
is automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill & CASE
6.73 Stress Test System.
The secondary endpoints will be the change in hs cTnI between the before and after ETT,
maximal exercise capacity (METs score), ST/HR slope (μV/bpm), maximal horizontal or down
slope ST segment depression (mm) with exercise. Secondary end points other than cTnI are
automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill & CASE
6.73 Stress Test System.
The null hypothesis is that there is no difference between in the ST/HR index (μV/bpm)
between the menstrual phases. The power is calculated to prove the alternative hypothesis in
which there is a 50 % difference between the ETT ST/HR index (μV/bpm). In a paired study
sample, with type I error of 5 % and type II error of 20 %, the sample size is calculated as
34 patients.
