A Phase 4 interventional study of N-acetylcysteine in Acute Myocardial Infarction, Euthyroid Sick Syndrome and Ischemic Heart Disease, sponsored by Federal University of Rio Grande do Sul. Completed at 2 sites in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-03-31.
Sponsored by Federal University of Rio Grande do Sul · Phase 4, Interventional, and Treatment
The propose of this study is to determine whether N-acetylcysteine is effective in reversing the changes in thyroid hormones seen in critical illness, known as the low T3 syndrome.
The low T3 syndrome or nonthyroidal illness is characterized by low levels of T3, normal or high normal levels of rT3, low or normal levels of T4 and inappropriately normal or low levels of TSH. These changes affect up to 75% of patients and have prognostic implications.
Interleukin-6 (IL6) seems to have a causative role in the pathogenesis of nonthyroidal illness. There is evidence that the reduction in serum T3 was inversely associated with serum IL-6, while the rT3 have a positive association. The mechanism of action of cytokines on the metabolism of thyroid hormones has not been determined and the potential role of cytokines on the deiodases has been the focus of research.
In a cell culture model study, IL-6 was able to suppress the conversion of T4 to T3 by deiodases type 1 and 2 and stimulate the inactivation of T3 by deiodase type 3, a situation similar to nonthyroidal illness. The use of N-acetylcysteine prevented this alterations, been consistent with the hypothesis that IL6 inhibits the function of the deiodases by increasing the oxygen reactive species and by consuming gluthathione or some gluthathione dependent cofactor.
Considering the absence of human studies evaluating the use of N-acetylcysteine in nonthyroidal illness, the aim of this study is to investigate whether NAC has in vivo effect on changes of thyroid hormones.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 83 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Federal University of Rio Grande do Sul is the lead sponsor of 118 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.
Drug: N-acetylcysteine
No intervention
in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours
Also known as: NAC, acetylcysteine
Serum T3 Levels at 48 Hours
Time frame: 48 hours
Consecutive patients with a diagnosis of acute myocardial infarction within 12 hours of evolution who underwent primary percutaneous coronary intervention and were admitted to the emergency and intensive care units of two tertiary hospitals in southern Brazil were recruited.
| Milestone | N-acetylcysteine | no Intervention |
|---|---|---|
| Started | 34 | 34 |
| Completed | 34 | 33 |
| Not completed | 0 | 1 |
| Withdrew: Death | 0 | 1 |
| ng/dL | N-acetylcysteine | no Intervention |
|---|---|---|
| Serum T3 Levels at 48 Hours | 93.5 ± 20.1 | 96.5 ± 20.2 |
Collected over Adverse reactions were collected during drug infusion period (48 hours). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| N-acetylcysteine | — | 0/34 (0%) | 0/34 (0%) |
| no Intervention | — | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | N-acetylcysteine | no Intervention | Total |
|---|---|---|---|
| Mean | 56.9 ± 9.4 | 57.4 ± 8.4 | 57 ± 9 |
| Sex: Female, Male(Participants) | N-acetylcysteine | no Intervention | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 27 | 24 | 51 |
| Region of Enrollment(participants) | N-acetylcysteine | no Intervention | Total |
|---|---|---|---|
| Brazil | 34 | 33 | 67 |
| TSH(mcIU/mL) | N-acetylcysteine | no Intervention | Total |
|---|---|---|---|
| Mean | 1.7 ± 1.2 | 1.6 ± 1.1 | 1.6 ± 1.2 |
| T3(ng/dL) | N-acetylcysteine | no Intervention | Total |
|---|---|---|---|
| Mean | 100.4 ± 16.5 | 98.7 ± 20.7 | 99.3 ± 17.4 |
| T4(mcg/dL) | N-acetylcysteine | no Intervention | Total |
|---|---|---|---|
| Median | 7.4 ± 1.9 | 7.4 ± 1.4 | 7.4 ± 1.5 |
| FT4(ng/dL) | N-acetylcysteine | no Intervention | Total |
|---|---|---|---|
| Mean | 1.1 ± 0.2 | 1.1 ± 0.3 | 1.1 ± 0.2 |
| rT3(ng/dL) | N-acetylcysteine | no Intervention | Total |
|---|---|---|---|
| Mean | 54.7 ± 8.1 | 55.2 ± 6.1 | 55 ± 7.1 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Federal University of Rio Grande do Sul