Evidence map›Paper›PMID 25872532›Full record

ArticleTrials2015

Thyroxine in acute myocardial infarction (ThyrAMI) - levothyroxine in subclinical hypothyroidism post-acute myocardial infarction: study protocol for a randomised controlled trial.

Avais Jabbar, Lorna Ingoe, Simon Pearce, Azfar Zaman, Salman Razvi

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 63 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Nanoscale organization of cardiac calcium channels is dependent on thyroid hormone status.American journal of physiology. Heart and circulatory physiology · 2024
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  19. Review
  20. Thyroid hormones and cardiovascular disease.Nature reviews. Cardiology · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Avais JabbarInstitute of Genetic Medicine, Newcastle University, Central Parkway, Newcastle upon Tyne, NE1 3BZ, UK. avais.jabbar@ncl.ac.uk.
Lorna IngoeDepartment of Endocrinology, Gateshead Health NHS Foundation trust, Sheriff Hill, Gateshead, NE9 6SX, UK. lorna.ingoe@ghnt.nhs.uk.
Simon PearceInstitute of Genetic Medicine, Newcastle University, Central Parkway, Newcastle upon Tyne, NE1 3BZ, UK. simon.pearce@newcastle.ac.uk.
Azfar ZamanDepartment of Cardiology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Road, NE7 7DN, Newcastle upon Tyne, UK. azfar.zaman@nuth.nhs.uk.
Salman RazviInstitute of Genetic Medicine, Newcastle University, Central Parkway, Newcastle upon Tyne, NE1 3BZ, UK. salman.razvi@ncl.ac.uk.
Gateshead Health NHS Foundation Trust · GBNewcastle University · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GB

Funding

Department of Health CDF-2012-05-231Medical Research Council G0500783
6 · The paper itself

Abstract

backgroundCardiac disease is the most common cause of morbidity and mortality in the United Kingdom. Even minor changes in thyroid hormone concentration may impact adversely on the cardiovascular system. Subclinical hypothyroidism (SCH) after admission for an acute cardiac problem has been associated with an increase in cardiac mortality and overall death. We have designed protocols for a prospective observational study to assess the association of thyroid function at the time of acute myocardial infarction (AMI) with cardiovascular outcomes, and a double-blinded randomised placebo-controlled trial of levothyroxine to evaluate its effect on LV function and vascular health. METHODS/

designThyrAMI 1: This will be a prospective longitudinal observational study of patients with AMI that will be followed for 24 months to study the association between thyroid status at the time of AMI (within 24 hours of diagnosis) with vascular outcomes. ThyrAMI 2: This will be a prospective double-blinded randomised placebo-controlled trial of levothyroxine of 12 months duration in patients with AMI and SCH.

settingPatients will be recruited from five hospitals in the North East of England.

participantsOne hundred patients with thyroid function tests within the subclinical hypothyroid range upon admission with an AMI and no previous history of thyroid disease.

interventionLevothyroxine will be administered at a starting dose of 25 mcg once daily, which will be increased at intervals if needed to maintain a TSH level between 0.4 to 2.5 mU/L, versus a placebo. RANDOMISATION: Participants will be randomized with a computerised randomisation algorithm, stratified by type of MI (NSTEMI versus STEMI), in a 1:1 ratio to levothyroxine therapy or placebo (as container or bottle numbers), starting within 21 (+/- 7) days of AMI. BLINDING: Assignment to either the LT4 or placebo arm will be double-blinded. OUTCOMES: The outcome will be the effect of levothyroxine on ventricular function, endothelial function and blood coagulability and rheology. DISCUSSION: There is evidence to suggest that treatment of SCH can improve cardiovascular parameters. Therefore, ThyrAMI 1 and ThyrAMI 2 will be the first trials investigating SCH in AMI to give a better insight into whether thyroid hormone levels are a key target for improving cardiovascular outcomes.

trial registrationISRCTN number: ISRCTN52505169 . Date of registration: 09/01/2015.

Indexed as

HypothyroidismMyocardial InfarctionThyroxineAsymptomatic DiseasesBiomarkersDouble-Blind MethodEnglandFemaleHumansLongitudinal StudiesMaleProspective StudiesRandomized Controlled Trials as TopicResearch DesignThyroid Function TestsThyrotropinBiomarkersThyrotropinThyroxine

Identifiers

PMID25872532
PMCPMC4379597
OpenAlexW2049307843

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.