The role of hormones in acute coronary syndrome (heart attack)
| ISRCTN | ISRCTN62480360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62480360 |
| Secondary identifying numbers | 35D/2012 |
- Submission date
- 08/12/2023
- Registration date
- 18/12/2023
- Last edited
- 18/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
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
| Study design | Single-center cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Significance of dehydroepiandrosterone-sulfate and gonadal sex hormones in acute coronary syndrome - sex-based differences |
| Study acronym | SHACS |
| Study hypothesis | 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 |
| Condition | 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 | 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) 2. Coronary disease severity, measured using SYNTAX score after CAG 3. Total 17β-estradiol [E2], total testosterone [T], dehydroepiandrosterone-sulfate [DHEA-S] measured using blood samples drawn 48 hours after symptom onset |
| Secondary outcome measures | Patient information on obesity, diabetes mellitus and incidence of revascularizations, reinfarctions and deaths after one- year follow up measured using patient records. |
| Overall study start date | 01/07/2011 |
| Overall study end date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 95 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 175 |
| Participant inclusion criteria | Adult men and women admitted to hospital with acute coronary syndrome. |
| Participant 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. |
| Recruitment start date | 01/05/2011 |
| Recruitment end date | 30/06/2014 |
Locations
Countries of recruitment
- Bulgaria
Study participating centre
Sofia
1431
Bulgaria
Sponsor information
University/education
15 Acad Ivan Geshov street
Sofia
1431
Bulgaria
| Phone | +359 2 9152-139 |
|---|---|
| otdel-nauka@mu-sofia.bg | |
| Website | https://mu-sofia.bg |
"ROR" |
https://ror.org/01n9zy652 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- Bulgaria
Results and Publications
| Intention to publish date | 30/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Three articles published. Planned publications in a high-impact peer-reviewed journal. |
| 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? |
|---|---|---|---|---|---|
| Protocol file | 13/12/2023 | No | No |
Additional files
Editorial Notes
13/12/2023: Trial's existence confirmed by Ethics committee of Medical University, Sofia
