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Reverse the HYpoTHyroid Status in Acute Myocardial InfarCtion (RHYTHMIC)

Information source: Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Infarction; Hypothyroidism

Intervention: Levothyroxine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Cardiovascular Institute & Fuwai Hospital

Official(s) and/or principal investigator(s):
Yi-Da Tang, MD,PhD, Principal Investigator, Affiliation: Cardiovascular Institute & Fuwai Hospital

Overall contact:
Wen-Yao Wang, MD,PhD Candidate, Phone: 8618810488381, Ext: 861088396171, Email: wwypumc@126.com

Summary

Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1: 1 ratio to levothyroxine group or standard therapy group.

Clinical Details

Official title: Reverse the HYpoTHyroid Status in Acute Myocardial InfarCtion (RHYTHMIC)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging

Secondary outcome:

Myocardial perfusion and metabolism detected by 99Tcm-MIBI SPECT and 18F-FDG PET imaging

The severity of myocardial fibrosis assessed by late-gadolinium enhancement cardiac magnetic resonance imaging(cMRI-LGE)

Major adverse cardiac and cerebrovascular events

Death by any cause

Detailed description: The primary hypothesis is that reversing the hypothyroid status with levothyroxine on top of standard therapy for AMI is safe and has beneficial effects on cardiac function, myocardial perfusion/metabolism and myocardial fibrosis.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Age 18 - 75, male or non-pregnant female;

2. Is diagnosed acute myocardial infarction and received primary percutaneous coronary intervention (PCI); 3. With presence of hypothyroid status (i. e., TSH >7. 0 mIU/L and (or) fT3 <1. 79 pg/mL); 4. Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form. Exclusion Criteria: 1. Those who have participated in other drug or therapeutic equipment clinical trials but do not reach the main study endpoint time limit; 2. Symptoms of severe heart failure (Killip Class III and above); 3. Severely impaired renal function before surgery: serum creatinine > 2. 0mg/dl; 4. Impaired liver function before surgery: Serum GPT > 120U/L; 5. Those who have prior thyroid diseases and already on levothyroxine or anti-thyroid medicines; 6. Those taking medicine which can affect the test of thyroid function; 7. Patients who plan to undergo coronary artery bypass grafting or other surgery within 3 months; 8. Those having prior myocardial infarction; 9. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Locations and Contacts

Wen-Yao Wang, MD,PhD Candidate, Phone: 8618810488381, Ext: 861088396171, Email: wwypumc@126.com

Fuwai Cardiovascular Hospital, Beijing 100037, China; Recruiting
Kuo Zhang, MD,PhD Candidant, Phone: +86 18813019602, Email: zk1989y@163.com
Additional Information

heart attack

hypothyroidism

levothyroxine

Starting date: August 2015
Last updated: August 13, 2015

Page last updated: August 23, 2015

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