Myocardial InfarctionNCT03829605
Plasma Hydrogen Sulfide, Nitric Oxide and Stress Hyperglycemia in Acute Myocardial Infarction
An observational study of Myocardial Infarction, run by Assiut University.
Trial summary
Acute myocardial infarction (AMI) can cause heart failure, an irregular heartbeat, cardiogenic shock, or cardiac arrest. It is the major cause of morbidity and mortality in the general population. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Measurement of hydrogen sulfide
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2019to 20 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Acute myocardial infarction
Who may be able to join
- Patients with confirmed diagnosis of AMI-
- Patients of age 18 years or more who are willing to participate in the study and give their consent for same.
Who cannot join
- Patients with congenital heart diseases, alcoholics with a past history of liver disease, pulmonary embolus, sepsis, chest trauma, and renal failure were excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Plasma Measurement of Hydrogen Sulfide, Nitric Oxide and Stress Hyperglycemia in Acute Myocardial Infarction
Acute myocardial infarction (AMI) can cause heart failure, an irregular heartbeat, cardiogenic shock, or cardiac arrest. It is the major cause of morbidity and mortality in the general population. The diagnosis of AMI is complex basing on the clinical history, physical examination, cardiac markers, and a chest radiograph. Besides, considering that the mechanisms linking activation of inflammation and ACS are complex as well, progress in diagnosis and therapy improves little
Read the detailed description
The World Health Organization (WHO) indexed cardiovascular disease (CVD) as a leading foundation for human death in developing as well as developed countries. Ischemic necrosis of the myocardium is called myocar¬dial infarction. Despite improvements in medical and interventional therapies in recent years, acute myocar¬dial infarction is still an important cause of mortal¬ity and morbidity. Hydrogen sulfide (H2S) is a colorless, water-soluble gas and is an endogenously produced labile diffusible mediator with multiple roles in the cardiovascular system in health and disease. H2S is endogenously generated, and cystathionine-β-synthase (CBS), cystathionine-γ-lyase (CSE), and 3-mercaptopyruvate sulfurtransferase (3-MST) are key enzymes involved in its biological production. Once interacting with carbon monoxide and nitric oxide, H2S will initiate a unique gaseous signaling net¬work and participate in the regulation of multiple patho¬physiological processes. Plasma H2S levels negatively correlated with HbA1c, duration of diabetes, and systolic and diastolic blood pressures.
- Conditions
- Myocardial Infarction
- Being tested
- Measurement of hydrogen sulfide
- Keywords
- Hydrogen sulfide, Nitric oxide, Stress hyperglycemia, Acute coronary syndrome
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of hydrogen sulfideOther
Hydrogen sulfide will be measured by ELISA and correlated with nitric oxide and hyperglycemia
| Study group | Role | What they receive |
|---|---|---|
| Group I: | Fifty AMI patients on admission Receives: Other: Measurement of hydrogen sulfide | |
| Group II: | The previous AMI patients after 12 hours Receives: Other: Measurement of hydrogen sulfide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference of hydrogen sulfide before and after treatment
Hydrogen sulfide mean difference will be measured by ELISA in myocardial infarction.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start15 Feb 2019 (estimated)
- Primary completion20 Apr 2019 (estimated)
- Study completion20 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham I El-mahdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829605
- Sponsor's protocol ID
- Myocardial infarction
- Status last verified
- Feb 2019
- First submitted
- 1 Feb 2019
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suzuki K, Sagara M, Aoki C, Tanaka S, Aso Y. Clinical Implication of Plasma Hydrogen Sulfide Levels in Japanese Patients with Type 2 Diabetes. Intern Med. 2017;56(1):17-21. doi: 10.2169/internalmedicine.56.7403. Epub 2017 Jan 1.
PubMed 28049995Peter EA, Shen X, Shah SH, Pardue S, Glawe JD, Zhang WW, Reddy P, Akkus NI, Varma J, Kevil CG. Plasma free H2S levels are elevated in patients with cardiovascular disease. J Am Heart Assoc. 2013 Oct 23;2(5):e000387. doi: 10.1161/JAHA.113.000387.
PubMed 24152982Kuang Q, Xue N, Chen J, Shen Z, Cui X, Fang Y, Ding X. Low Plasma Hydrogen Sulfide Is Associated with Impaired Renal Function and Cardiac Dysfunction. Am J Nephrol. 2018;47(5):361-371. doi: 10.1159/000489606. Epub 2018 May 18.
PubMed 29779029Marfella R, Siniscalchi M, Esposito K, Sellitto A, De Fanis U, Romano C, Portoghese M, Siciliano S, Nappo F, Sasso FC, Mininni N, Cacciapuoti F, Lucivero G, Giunta R, Verza M, Giugliano D. Effects of stress hyperglycemia on acute myocardial infarction: role of inflammatory immune process in functional cardiac outcome. Diabetes Care. 2003 Nov;26(11):3129-35. doi: 10.2337/diacare.26.11.3129.
PubMed 14578250
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Measurement of Hydrogen Sulfide, Nitric Oxide and Stress Hyperglycemia in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03829605
- Acronym / sponsor ID
- Myocardial infarction
- Conditions
- Myocardial Infarction
- Keywords
- Hydrogen sulfide, Nitric oxide, Stress hyperglycemia, Acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 20 Apr 2019 (estimated)
- Study completion
- 20 May 2019 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute myocardial infarction (AMI) can cause heart failure, an irregular heartbeat, cardiogenic shock, or cardiac arrest. It is the major cause of morbidity and mortality in the general population. The diagnosis of AMI is complex basing on the clinical history, physical examination, cardiac markers, and a chest radiograph. Besides, considering that the mechanisms linking activation of inflammation and ACS are complex as well, progress in diagnosis and therapy improves little
Detailed description
The World Health Organization (WHO) indexed cardiovascular disease (CVD) as a leading foundation for human death in developing as well as developed countries. Ischemic necrosis of the myocardium is called myocar¬dial infarction. Despite improvements in medical and interventional therapies in recent years, acute myocar¬dial infarction is still an important cause of mortal¬ity and morbidity. Hydrogen sulfide (H2S) is a colorless, water-soluble gas and is an endogenously produced labile diffusible mediator with multiple roles in the cardiovascular system in health and disease. H2S is endogenously generated, and cystathionine-β-synthase (CBS), cystathionine-γ-lyase (CSE), and 3-mercaptopyruvate sulfurtransferase (3-MST) are key enzymes involved in its biological production. Once interacting with carbon monoxide and nitric oxide, H2S will initiate a unique gaseous signaling net¬work and participate in the regulation of multiple patho¬physiological processes. Plasma H2S levels negatively correlated with HbA1c, duration of diabetes, and systolic and diastolic blood pressures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: | – | Other: Measurement of hydrogen sulfideFifty AMI patients on admission |
| Group II: | – | Other: Measurement of hydrogen sulfideThe previous AMI patients after 12 hours |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Acute myocardial infarction
Key inclusion criteria (2 listed)
- Patients with confirmed diagnosis of AMI-
- Patients of age 18 years or more who are willing to participate in the study and give their consent for same.
Key exclusion criteria (1 listed)
- Patients with congenital heart diseases, alcoholics with a past history of liver disease, pulmonary embolus, sepsis, chest trauma, and renal failure were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of hydrogen sulfideHydrogen sulfide will be measured by ELISA and correlated with nitric oxide and hyperglycemia | Other | Group I:, Group II: |
Primary outcome
The mean difference of hydrogen sulfide before and after treatment
Time frame: 12 hours
Hydrogen sulfide mean difference will be measured by ELISA in myocardial infarction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 28049995Suzuki K, Sagara M, Aoki C, Tanaka S, Aso Y. Clinical Implication of Plasma Hydrogen Sulfide Levels in Japanese Patients with Type 2 Diabetes. Intern Med. 2017;56(1):17-21. doi: 10.2169/internalmedicine.56.7403. Epub 2017 Jan 1.
- Background: PubMed 24152982Peter EA, Shen X, Shah SH, Pardue S, Glawe JD, Zhang WW, Reddy P, Akkus NI, Varma J, Kevil CG. Plasma free H2S levels are elevated in patients with cardiovascular disease. J Am Heart Assoc. 2013 Oct 23;2(5):e000387. doi: 10.1161/JAHA.113.000387.
- Background: PubMed 29779029Kuang Q, Xue N, Chen J, Shen Z, Cui X, Fang Y, Ding X. Low Plasma Hydrogen Sulfide Is Associated with Impaired Renal Function and Cardiac Dysfunction. Am J Nephrol. 2018;47(5):361-371. doi: 10.1159/000489606. Epub 2018 May 18.
- Background: PubMed 14578250Marfella R, Siniscalchi M, Esposito K, Sellitto A, De Fanis U, Romano C, Portoghese M, Siciliano S, Nappo F, Sasso FC, Mininni N, Cacciapuoti F, Lucivero G, Giunta R, Verza M, Giugliano D. Effects of stress hyperglycemia on acute myocardial infarction: role of inflammatory immune process in functional cardiac outcome. Diabetes Care. 2003 Nov;26(11):3129-35. doi: 10.2337/diacare.26.11.3129.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact reham elmahdy, Dr (+201002714637, reham.elmahdy@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean difference of hydrogen sulfide before and after treatment (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03829605, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.