MARINARanolazine's Impact on Coronary Microvasculature in Non-Obstructive Atherosclerosis
Ranolazine
+ Placebo
Angina Pectoris+3
+ Cardiovascular Diseases
+ Heart Diseases
Treatment Study
Summary
Study start date: September 1, 2014
Actual date on which the first participant was enrolled.Heart disease is a leading cause of death worldwide, often involving issues with the large heart arteries. However, this study focuses on a less understood area - the very small heart arteries, known as the coronary microvasculature. This 'base of the iceberg' of cardiovascular disease is believed to contribute to reduced blood flow, symptoms, and negative outcomes. The study aims to better understand how dysfunction in these small arteries leads to such issues, particularly in individuals with non-obstructive atherosclerosis. A medicine called Ranolazine, approved by the U.S Food and Drug Administration to help with angina (chest pain), is being investigated in this study, as its effects on the coronary microvasculature are not yet fully understood. During this study, participants receive either Ranolazine or a placebo for 12 weeks. The impact of the treatment is measured using the Seattle Angina Questionnaire, specifically looking at changes in the frequency of angina episodes. This questionnaire scores health on a scale from 0 to 100, with higher scores indicating better health. A positive change in the angina frequency score suggests that participants are experiencing fewer angina episodes at the end of the 12 weeks compared to the start of the study. The study uses reliable diagnostic tools that do not rely solely on imaging, but also include hemodynamic measurements such as coronary flow reserve and hyperemic microcirculatory resistance, which are taken in a cardiac catheterization laboratory.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.26 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location