Thyroxine in Acute Myocardial Infarctio

Phase 1

• Conditions: Hypothyroidism and Acute Myocardial Infarction; MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001369-28-GB
• Lead Sponsor: Gateshead Health NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-23
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2100

Inclusion Criteria

For the observation study:

Adult males and females (aged 18 yrs or older).

Acute myocardial infarction diagnosed in the preceding 24 hours.

Participants in other research studies will be eligible for inclusion as this is an observational study.

For the interventional study:

Males and females aged between 18-75 yrs.

Serum TSH between 4.01 -10.00 mU/L with normal free thyroxine levels (9 – 25 pmol/L) on two occasions (on day of admission for heart attack (AMI) and 7-10 days after AMI).

Acute myocardial infarction diagnosed on admission to hospital (chest pain with dynamic ECG changes or increase troponin enzymes (at least a fourfold increase above normal range).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

For the observation study:

Patients who are unable to provide informed consent.

Those with advanced malignancy (who are unlikely to survive for more than 6 months in the opinion of local investigator).

On medications that can affect thyroid function such as amiodarone, lithium, carbimazole and propylthiouracil. Patients on levothyroxine will be included but their results will be analysed separately.

For the interventional study:

Patients on medications affecting thyroid function (levothyroxine, carbimazole, propylthiouracil, amiodarone, lithium).

Patients who are unable to provide written informed consent.

Patients with advanced malignancy (who, in the opinion of the investigator, is unlikely to survive for more than 6 months).

Patients with sustained ventricular tachycardia requiring treatment which occurs >24hrs after myocardial re-perfusion/revascularisation.

Patients who have contra-indications to MR scanning (cardiac pacemaker, metallic heart valves, cochlear implants, coronary artery stents incompatible with MR scanning, etc.).

Patients who are unlikely or unwilling, in the opinion of the investigator, to attend for study specific visits.

Participants whose serum TSH is >10.0 or <4.0 on either occasion.

Patients who are already participating in another interventional study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified