Abstract W MP115: Patients With ICH Have Dynamic Electrocardiographic Changes Over Time
Background: Few studies have reported electrocardiographic (ECG) changes in patients with intracerebral hemorrhage (ICH). We performed a randomized controlled trial evaluating the safety of pioglitazone (PIO) versus placebo in patients with ICH (NCT00827892). Cardiac toxicity was evaluated with serial ECG.
Methods: Patients enrolled into the Safety of Pioglitazone for Hematoma Resolution in ICH (SHRINC) trial were randomly allocated 1:1 to either placebo or PIO. Patients received escalating doses of PIO daily for 3 days (high-dose phase) beginning within 24 hours of symptom onset, followed by a 30mg maintenance dose for the duration of treatment. Serial ECGs were performed at baseline and on days 1, 2, 3 and 90. Zero inflated Poisson regression was used to model the relationship between treatment with PIO and the likelihood of observing new important ECG findings during the high-dose phase.
Results: A total of 84 patients were enrolled in SHRINC (42 PIO, 42 placebo). At baseline, 60% of patients in both groups had important abnormal ECG findings, the most common being prolonged QT (Table 1a). During the high-dose phase, 51% in the PIO group and 46% in the placebo group developed at least one new important abnormal ECG finding (Table 1b). In multivariable analysis, after controlling for age, diabetes, baseline PTT, baseline systolic and diastolic blood pressure, PIO was not associated with the likelihood of developing any new important abnormal ECG findings, Rate Ratio 1.27, 95% CI (0.71, 2.28), p=0.42.
Conclusions: ECG findings in this cohort of ICH patients were dynamic in the first 72 hours with most patients having abnormal ECGs at baseline and almost half of the cohort developing new findings. The addition of a placebo group allowed us to incorporate the natural history of ICH in our analysis to more clearly understand the effect of PIO. We did not find cardiac toxicity due to PIO as evidenced by ECG changes during the follow up period.
Author Disclosures: N.R. Gonzales: None. C. Cai: None. R. Bowry: None. D. Ayish: None. R. Pandurengan: None. M. Sline: None. A.E. Denktas: None. S. Ramanathan: None. A.D. Barreto: None. T. Wu: None. N. Ifejika: None. A.Z. Sharrief: None. A. Sarraj: None. S.I. Savitz: None. M.H. Rahbar: None. X. Zhao: None. J. Aronowski: None. J.C. Grotta: None.
This research has received full or partial funding support from the American Heart Association, National Center.
- © 2015 by American Heart Association, Inc.