Dataset Information

Ayurvedic Treatment of Acute Ischemic Stroke: A Prospective Observational Study.

ABSTRACT:

Background

The western medical arsenal for treating stroke is rather limited, and the only treatments shown to improve outcomes are not accessible to most in the third world. Even in the developed world, many patients present too late to receive thrombolysis or thrombectomy. Stroke patients in India commonly use Ayurvedic therapies, but there are no published data regarding the efficacy or safety of these therapies, the latter being of particular concern in acute ischemic stroke (AIS).

Objective

To obtain preliminary data on the safety and efficacy of stand-alone whole-system Ayurvedic treatment in AIS.

Methods

We present here an observational study prospectively comparing outcomes in 2 cohorts of AIS patients treated with whole-system classical Ayurveda (n?=?13) or conservative (nonthrombolytic, noninterventional) western biomedicine (n?=?20).

Results

Pooled analysis of outcomes did not show statistically significant differences in mortality (15.38% vs 15%, P?=?1.00), nonfatal adverse event rates (15.38% vs 30%, P?=?.4), or functional disability measures. A paired analysis performed using a matching algorithm to reduce baseline disparities between the cohorts also showed no statistically significant differences in outcomes.

Conclusions

The safety profiles of classical Ayurveda and conservative western biomedicine in AIS are similar. This is the first ever report of stand-alone Ayurvedic therapy in AIS. Our results support the conduct of a randomized controlled trial to study the efficacy of Ayurvedic treatment of AIS.

SUBMITTER: Harini JA

PROVIDER: S-EPMC6545648 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Ayurvedic Treatment of Acute Ischemic Stroke: A Prospective Observational Study.

Harini J Aarthi JA Luthra Avineet A Madeka Shrey S Shankar Prasan P Mandava Pitchaiah P Pervaje Ravishankar R Aaron Sanjith S Purushotham Archana A

Global advances in health and medicine 20190530

<h4>Background</h4>The western medical arsenal for treating stroke is rather limited, and the only treatments shown to improve outcomes are not accessible to most in the third world. Even in the developed world, many patients present too late to receive thrombolysis or thrombectomy. Stroke patients in India commonly use Ayurvedic therapies, but there are no published data regarding the efficacy or safety of these therapies, the latter being of particular concern in acute ischemic stroke (AIS).<h ...[more]

PMID: 31211006

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Project description:BackgroundElevated cardiac troponin, which indicates cardiomyocyte injury, is common after acute ischemic stroke and is associated with poor functional outcome. Myocardial injury is part of a broad spectrum of cardiac complications that may occur after acute ischemic stroke. Previous studies have shown that in most patients, the underlying mechanism of stroke-associated myocardial injury may not be a concomitant acute coronary syndrome. Evidence from animal research and clinical and neuroimaging studies suggest that functional and structural alterations in the central autonomic network leading to stress-mediated neurocardiogenic injury may be a key underlying mechanism (ie, stroke-heart syndrome). However, the exact pathophysiological cascade remains unclear, and the diagnostic and therapeutic implications are unknown.ObjectiveThe aim of this CORONA-IS (Cardiomyocyte injury following Acute Ischemic Stroke) study is to quantify autonomic dysfunction and to decipher downstream cardiac mechanisms leading to myocardial injury after acute ischemic stroke.MethodsIn this prospective, observational, single-center cohort study, 300 patients with acute ischemic stroke, confirmed via cerebral magnetic resonance imaging (MRI) and presenting within 48 hours of symptom onset, will be recruited during in-hospital stay. On the basis of high-sensitivity cardiac troponin levels and corresponding to the fourth universal definition of myocardial infarction, 3 groups are defined (ie, no myocardial injury [no cardiac troponin elevation], chronic myocardial injury [stable elevation], and acute myocardial injury [dynamic rise/fall pattern]). Each group will include approximately 100 patients. Study patients will receive routine diagnostic care. In addition, they will receive 3 Tesla cardiovascular MRI and transthoracic echocardiography within 5 days of symptom onset to provide myocardial tissue characterization and assess cardiac function, 20-min high-resolution electrocardiogram for analysis of cardiac autonomic function, and extensive biobanking. A follow-up for cardiovascular events will be conducted 3 and 12 months after inclusion.ResultsAfter a 4-month pilot phase, recruitment began in April 2019. We estimate a recruitment period of approximately 3 years to include 300 patients with a complete cardiovascular MRI protocol.ConclusionsStroke-associated myocardial injury is a common and relevant complication. Our study has the potential to provide a better mechanistic understanding of heart and brain interactions in the setting of acute stroke. Thus, it is essential to develop algorithms for recognizing patients at risk and to refine diagnostic and therapeutic procedures.Trial registrationClinicaltrials.gov NCT03892226; https://www.clinicaltrials.gov/ct2/show/NCT03892226.International registered report identifier (irrid)DERR1-10.2196/24186.

Project description:Levels of the cardiac muscle regulatory protein troponin T (cTnT) are frequently elevated in patients with acute ischemic stroke and elevated cTnT predicts poor outcome and mortality. The pathomechanism of troponin release may relate to co-morbid coronary artery disease and myocardial ischemia or, alternatively, to neurogenic cardiac damage due to autonomic activation after acute ischemic stroke. Therefore, there is uncertainty about how acute ischemic stroke patients with increased cTnT levels should be managed regarding diagnostic and therapeutic workup.The primary objective of the prospective observational trial TRELAS (TRoponin ELevation in Acute ischemic Stroke) is to investigate the frequency and underlying pathomechanism of cTnT elevation in acute ischemic stroke patients in order to give guidance for clinical practice. All consecutive patients with acute ischemic stroke admitted within 72 hours after symptom onset to the Department of Neurology at the Campus Benjamin Franklin of the University Hospital Charité will be screened for cTnT elevations (i.e. ? 0.05 ?g/l) on admission and again on the following day. Patients with increased cTnT will undergo coronary angiography within 72 hours. Diagnostic findings of coronary angiograms will be compared with age- and gender-matched patients presenting with Non-ST-Elevation myocardial infarction to the Department of Cardiology. The primary endpoint of the study will be the occurrence of culprit lesions in the coronary angiogram indicating underlying co-morbid obstructive coronary artery disease. Secondary endpoints will be the localization of stroke in the cerebral imaging and left ventriculographic findings of wall motion abnormalities suggestive of stroke-induced global cardiac dysfunction.TRELAS will prospectively determine the frequency and possible etiology of troponin elevation in a large cohort of ischemic stroke patients. The findings are expected to contribute to clarify pathophysiologic concepts of co-morbid cardiac damage in ischemic stroke patients and also to provide a basis for clinical recommendations for cardiac workup of such patients.clinicaltrials.gov NCT01263964.

Dataset Information

Ayurvedic Treatment of Acute Ischemic Stroke: A Prospective Observational Study.

Background

Objective

Methods

Results

Conclusions

Publications

Ayurvedic Treatment of Acute Ischemic Stroke: A Prospective Observational Study.

Similar Datasets

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