The role of hormones in acute coronary syndrome (heart attack)
| ISRCTN | ISRCTN62480360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62480360 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 35D/2012 |
| Sponsor | Medical University of Sofia |
| Funder | Medical University Sofia |
- Submission date
- 08/12/2023
- Registration date
- 18/12/2023
- Last edited
- 20/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Revised for an 18-year-old audience: Estrogens help protect the heart in the early stages of life. However, a specific type of estrogen called 17β-estradiol (E2) can speed up the progression of a condition called atherosclerosis, which involves the buildup of plaque in the arteries.
Who can participate?
Adult men and women diagnosed with acute coronary syndrome, admitted to hospital, who received catheter-based coronary reperfusion when appropriate.
What does the study involve?
We're studying the levels of certain hormones (E2, total testosterone [T], and dehydroepiandrosterone-sulfate [DHEA-S]) when patients are admitted to the hospital. We're also looking at their relationship with other things like oxidized low-density lipoproteins (oxDL), extracellular superoxide dismutase (ecSOD), high-sensitive C-reactive protein (CRP), white blood cell counts (WBC), and cardiac enzymes (creatine kinase [CK], the CK Muscle-Brain fraction [CK-MB], and high-sensitive troponin T [hsTnT]). This assessment is done within two hours after a procedure to clear blockages in the heart arteries, called coronary revascularization, which can involve angioplasty with or without stenting.
We're using something called the SYNTAX score to measure how severe the coronary disease is based on the results of a test called coronary angiography.
We're following these patients for a year and checking CRP, oxLDL, and ecSOD again. We're also keeping track of any bad events like another heart attack (reinfarction), additional procedures to clear arteries (revascularizations), and deaths.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Medical University of Sofia (Bulgaria)
When is the study starting and how long is it expected to run for?
Who is funding the study?
Medical University of Sofia (Bulgaria)
Who is the main contact?
Dr Niya Semerdzhieva, niaemilova@yahoo.com
Contact information
Public, Scientific, Principal investigator
21, 'Totleben', Str
Sofia
1431
Bulgaria
 ORCID ID |
0000-0003-1878-9807 |
|---|---|
| Phone | +359 988962418 |
| niaemilova@yahoo.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-center cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Significance of dehydroepiandrosterone-sulfate and gonadal sex hormones in acute coronary syndrome - sex-based differences |
| Study acronym | SHACS |
| Study objectives | Sex steroids (dehydroepiandrosterone-sulfate [DHEA-S], 17-beta estradiol [E2], total testosterone [T]) in the acute phase of coronary syndrome are associated with the peak levels of oxidized low-density lipoproteins (oxLDL), extracellular superoxide dismutase (ecSOD), high-sensitive C-reactive protein (CRP), white blood cell counts (WBC) and cardiac enzymes (creatine kinase [CK], the CK Muscle-Brain fraction [CK-MB], and high-sensitive troponin T [hsTnT]) and with adverse events - a year after ACS. |
| Ethics approval(s) |
Approved 30/05/2012, Ethics committee of Medical University (15 Acad Ivan Geshov str., Sofia, 1431, Bulgaria; +359 2 9152157; atanasova@mu-sofia.bg), ref: 81/30/05/2012 |
| Health condition(s) or problem(s) studied | Acute coronary syndrome |
| Intervention | Sex steroids (E2, total testosterone [T]) and DHEA-S, oxidized low-density lipoproteins, high-sensitive C-reactive protein (CRP), white blood cell counts (WBC), and cardiac enzymes (creatine kinase [CK], the CK Muscle-Brain fraction [CK-MB], and high-sensitive troponin T [hsTnT]) were measured at admission. The inflammatory and myocardial injury markers were evaluated within two hours after coronary revascularization. The SYNTAX score gauged coronary disease severity from coronary angiography results. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Oxidized low-density lipoproteins (oxLDL), high-sensitive C-reactive protein (hsCRP), white blood cell counts (WBC), and cardiac enzymes (creatine kinase [CK], Muscle-Brain fraction of CK [CPK-MB], high-sensitive troponin T [hsTnT]) were evaluated in plasma obtained within two hours of coronary angiography (CAG) |
| Key secondary outcome measure(s) |
Patient information on obesity, diabetes mellitus and incidence of revascularizations, reinfarctions and deaths after one- year follow up measured using patient records. |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 95 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 175 |
| Key inclusion criteria | Adult men and women admitted to hospital with acute coronary syndrome. |
| Key exclusion criteria | Acute infectious disease, any diagnosed neoplastic disease; fracture, physical trauma or surgical procedure a month before and after the inclusion period and at the end of the follow-up. |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- Bulgaria
Study participating centre
Sofia
1431
Bulgaria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Individual participant data - available on request; contact: Dr. Niya Emilova Semerdzhieva, e-mail : niaemilova@yahoo.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/06/2025 | 18/06/2025 | Yes | No | |
| Results article | 19/08/2025 | 20/08/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 13/12/2023 | No | No |
Additional files
- 44726 Protocol.pdf
- Protocol file
Editorial Notes
20/08/2025: Publication reference added.
18/06/2025: Publication reference added.
13/12/2023: Trial's existence confirmed by Ethics committee of Medical University, Sofia
