Heart InjuriesNCT03017157
Subclinical Hypothyroidism and Acute Anterior Myocardial Infarction: Is it Cardio-protective or Not?
An observational study of Heart Injuries, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The study plans to investigate whether recovery of the heart function after acute anterior myocardial infarction is dependent upon improvement in thyroid gland functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Injuries
- What is being tested?
- Echo-cardiogram and Blood test
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have suffered anterior myocardial infarction who have been hospitalized in our hospital's cardiac unit.
Who may be able to join
- Have suffered anterior myocardial infarction
Who cannot join
- Do not receive thyroid treatment
- No history of ischemic heart disease
Trial locations and contacts
1 site in 1 country.
Rami Abo Fane, MD, PhD contact
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Rami Abo Fane, MD, PhD, ramia@hy.health.gov.il
Rami Abo Fane, MD, PhD
About this study
The study plans to investigate whether recovery of the heart function after acute anterior myocardial infarction is dependent upon improvement in thyroid gland functioning.
- Conditions
- Heart Injuries
- Being tested
- Echo-cardiogram, Blood test
- Medical subject headings
- Heart Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo-cardiogramOther
Patients will undergo echo-cardiogram to determine improvement in their heart function and this will be compared to thyroid function
Blood testOther
Blood test to determine thyroid function
| Study group | Role | What they receive |
|---|---|---|
| Anterior Myocardial Infarction | Patients who have suffered anterior myocardial infarction in our hospital Receives: Other: Echo-cardiogram; Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection Fraction Improvement
Improvement in ejection fraction as shown in echo-cardiogram
Measured: 40 days
Improvement in thyroid function
Thyroid stimulating hormone (TSH) level will be normal.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart InjuriesStudies of the same condition, open and under way.
- 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
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017157
- Sponsor's protocol ID
- 0096-16-HYMC
- Status last verified
- Jan 2017
- First submitted
- 21 Dec 2016
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Hypothyroidism and Acute Anterior Myocardial Infarction: Is it Cardio-protective or Not?
- ClinicalTrials.gov ID
- NCT03017157
- Acronym / sponsor ID
- 0096-16-HYMC
- Conditions
- Heart Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2017
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- 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.
The study plans to investigate whether recovery of the heart function after acute anterior myocardial infarction is dependent upon improvement in thyroid gland functioning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior Myocardial Infarction | – | Other: Echo-cardiogram, Other: Blood testPatients who have suffered anterior myocardial infarction in our hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have suffered anterior myocardial infarction who have been hospitalized in our hospital's cardiac unit.
Key inclusion criteria (1 listed)
- Have suffered anterior myocardial infarction
Key exclusion criteria (2 listed)
- Do not receive thyroid treatment
- No history of ischemic heart disease
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 |
|---|---|---|
| Echo-cardiogramPatients will undergo echo-cardiogram to determine improvement in their heart function and this will be compared to thyroid function | Other | Anterior Myocardial Infarction |
| Blood testBlood test to determine thyroid function | Other | Anterior Myocardial Infarction |
Primary outcome
Ejection Fraction Improvement
Time frame: 40 days
Improvement in ejection fraction as shown in echo-cardiogram
Improvement in thyroid function
Time frame: 40 days
Thyroid stimulating hormone (TSH) level will be normal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Heart Injuries
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Rami Abo Fane, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Injuries, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 2 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Rami Abo Fane, MD, PhD (ramia@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ejection Fraction Improvement (time frame: 40 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2017.