Dataset Information

Effect of Remote Ischemic Conditioning in Patients With Takotsubo Syndrome After Acute Stroke: Study Protocol for a Randomized Controlled Trial.

ABSTRACT: Introduction: Takotsubo syndrome (TTS) is an acute heart failure syndrome which is preceded by a variety of emotional or physical triggers, with central nervous system conditions being an important trigger. Remote ischemic conditioning (RIC) is a promising interventional treatment based on the probability that both TTS and acute coronary syndrome may respond similarly to interventions. The heart protection effect of RIC has been repeatedly confirmed in animal models and observational clinical trials; however, it has never been studied in patients with TTS after acute stroke in randomized clinical trials with a higher level of evidence. The present study will be a proof-of-concept study to determine whether RIC can reduce cardiac injury and eventually improve the heart function and clinical outcomes of TTS patients after acute stroke. Methods and Analysis: A single-center, outcome-assessor-blinded, randomized controlled trial (RCT) will be conducted to evaluate the effect of RIC in TTS patients after acute stroke. Major eligibility criteria include TTS patients diagnosed with acute stroke, which can be confirmed on computed tomography or magnetic resonance imaging; patients aged 18-75 years; patients admitted to a hospital within 48 h after the onset of acute stroke; and patients diagnosed with Takotsubo cardiomyopathy with an InterTAK diagnostic score ?50. A total of 60 eligible patients will be randomly allocated into either the RIC or the control group. The primary endpoint is a composite of death from any cause and major adverse cardiac and cerebrovascular events during the in-hospital period and at the 1- and 6-month follow-up. Ethics and dissemination: This study has been approved by the Medical Ethics Committee of Xuanwu Hospital, Capital Medical University ([2017] 072). The study findings will be presented at international conferences and published in a peer-reviewed journal. Trial registration: This study has been prospectively registered in the Chinese Clinical Trial Registry on September 10, 2018 (ChiCTR1800018290).

SUBMITTER: Wang T

PROVIDER: S-EPMC7212382 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of Remote Ischemic Conditioning in Patients With Takotsubo Syndrome After Acute Stroke: Study Protocol for a Randomized Controlled Trial.

Wang Tao T Xu Yueqiao Y Wang Ning N Qi Meng M Cheng Weitao W Qu Xin X

Frontiers in neurology 20200428

<b>Introduction:</b> Takotsubo syndrome (TTS) is an acute heart failure syndrome which is preceded by a variety of emotional or physical triggers, with central nervous system conditions being an important trigger. Remote ischemic conditioning (RIC) is a promising interventional treatment based on the probability that both TTS and acute coronary syndrome may respond similarly to interventions. The heart protection effect of RIC has been repeatedly confirmed in animal models and observational clin ...[more]

PMID: 32425872

Similar Datasets

Project description:Background and Aim: Remote ischemic conditioning is a procedure purported to reduce the ischemic injury of an organ. This study aimed to explore the efficiency and safety of remote ischemic conditioning in patients with acute ischemic stroke. We hypothesized that remote ischemic conditioning administered from the first day of hospital admission would improve the infarct volume and clinical outcome at 180 days. Material and Methods: We performed a unicentric double-blind randomized controlled trial. We included all patients consecutively admitted to an Emergency Neurology Department with acute ischemic stroke, ineligible for reperfusion treatment, up to 24 hours from onset. All subjects were assigned to receive secondary stroke prevention treatment along with remote ischemic conditioning on the non-paretic upper limb during the first 5 days of hospitalization, twice daily - a blood pressure cuff placed around the arm was inflated to 20 mmHg above the systolic blood pressure (up to 180 mmHg) in the experimental group and 30 mmHg in the sham group. The primary outcome was the difference in infarct volume (measured on brain CT scan) at 180 days compared to baseline, whereas the secondary outcomes included differences in clinical scores (NIHSS, mRS, IADL, ADL) and cognitive/mood changes (MoCA, PHQ-9) at 180 days compared to baseline. Results: We enrolled 40 patients; the mean age was 65 years and 60% were men. Subjects in the interventional group had slightly better recovery in terms of disability, as demonstrated by the differences in disability scores between admission and 6 months (e.g., the median difference score for Barthel was -10 in the sham group and -17.5 in the interventional group, for ADL -2 in the sham group and -2.5 in the interventional group), as well as cognitive performance (the median difference score for MoCA was -2 in the sham group and -3 in the interventional group), but none of these differences reached statistical significance. The severity of symptoms (median difference score for NIHSS = 5 for both groups) and depression rate (median difference score for PHQ-9 = 0 for both groups) were similar in the two groups. The median difference between baseline infarct volume and final infarct volume at 6 months was slightly larger in the sham group compared to the interventional group (p = 0.4), probably due to an initial larger infarct volume in the former. Conclusion: Our results suggest that remote ischemic conditioning might improve disability and cognition. The difference between baseline infarct volume and final infarct volume at 180 days was slightly larger in the sham group.

Dataset Information

Effect of Remote Ischemic Conditioning in Patients With Takotsubo Syndrome After Acute Stroke: Study Protocol for a Randomized Controlled Trial.

Publications

Effect of Remote Ischemic Conditioning in Patients With Takotsubo Syndrome After Acute Stroke: Study Protocol for a Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets