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Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
Plain-language guide to NCT03377465: not phased non-randomized trial of BNP (Nesiritide), 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03377465
- Phase
- not phased
- Status
- completed
- Start
- 2016-11-15
- Completion (planned or actual)
- 2017-11-30
- Participants
- 100 (actual)
- Design
- non-randomized, single-blind, prevention
- Conditions studied
- Embolic Stroke of Undetermined Source; Ischemic Stroke; Atrial Fibrillation and Flutter; Myocardial Infarction; Cardiac Tumor; Endocarditis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test BNP (Nesiritide).
In spite of a possibility of the therapy of stroke ( tissue plasminogen activator) and recognized most of risk factors there is expected that incidence rate on stroke connected with ageing of the society will be growing.
It had two arms (groups): Experimental Group (experimental) and Comparative group (active comparator).
Patients with stroke of undetermined cause age 18-65.
Healthy patients age 18-65.
The registry classes the interventions as diagnostic test.
More on the Plan
The risk factors of stroke can be divided into alterable and not alterable.
Importantly, the not alterable factors are: age, sex, race and genetic factors.
After the age of 55 the risk of stroke grows twice in every decade of life.
Moreover, it was alleged that incidence rate on stroke is more frequent at women than at men.
Who Took Part
Enrollment: 100 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Stroke of undetermined cause.
The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: unstable hypertension; atrial fibrillation; hyperthyroidism hard.
How the Study Was Run
Design: non-randomized, parallel-group and single-blind.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Only one side, usually the participants, was kept unaware of whether BNP (Nesiritide) was given.
Those kept unaware of assignments: investigator.
It started in 2016-11-15 with completion listed for 2017-11-30.
Its stated primary purpose is prevention.
What Was Measured
Primary outcome: physiological parameter (time frame: 24 months). physiological parameter (time frame: 24 months). physiological parameter (time frame: 24 months).
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of BNP (Nesiritide) in 100 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the BNP (Nesiritide) compound page, all human trials.
Our Notes on the Compound
BNP (Nesiritide): B-type natriuretic peptide, a 32-amino-acid heart hormone; nesiritide (Natrecor) is a recombinant form used in acute heart failure.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.