Clinical Trial: Ranolazine and Microvascular Angina by PET in the Emergency Department

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ranolazine and Microvascular Angina by PET in the Emergency Department (RAMP-ED)

Brief Summary: The purpose of this study is to determine the effectiveness of Ranolazine for the treatment chest pain from disease of small vessels of the heart also known as 'microvascular angina'.

Detailed Summary:

The Yale Chest Pain Center (CPC) is a unique clinical lab that provides an integrated interdisciplinary research team, access to high volume of chest pain patients largely free of coronary disease (93%) as well state of the art diagnostics including cardiac PET and a sophisticated system for serum processing and banking facilities. The CPC cohort represents a unique population with unrecognized microvascular disease and is often only accessible through the ED. We propose a one-year pilot study to understand the mechanisms of angina relief by Ranolazine (n=20) in patients with microvessel disease in the ED population as compared to controls (n=10) at baseline and at 1-month. In addition, changes in pain scores and function as measured by Seattle Angina Questionnaire (SAQ), recidivism and costs will be measured and correlated with changes in coronary flow reserve (CFR). Serum samples will be obtained and banked for future marker analysis as intermediate surrogates of outcomes.

Primary aim: To compare changes in coronary flow reserve as measured by cardiac PET in patients receiving Ranolazine versus controls.

Secondary aim: To determine if Ranolazine changes Seattle Angina Questionnaire (SAQ) scores in association with changes in Coronary Flow Reserve (CFR) versus controls.

Exploratory aim: To compare composite rate of return visits (office, emergency department and hospitalization) for chest pain within 4-weeks of enrollment between patients with and without Ranolazine.


Sponsor: Yale University

Current Primary Outcome: Coronary Flow Reserve [ Time Frame: 4 weeks ]

Compare changes in coronary flow reserve as measured by cardiac PET(Positron Emission Tomography) in patients receiving Ranolazine versus control. This is the ratio between stress and rest myocardial blood flow in response to stress.


Original Primary Outcome: Coronary Flow Reserve [ Time Frame: 4 weeks ]

Compare changes in coronary flow reserve as measured by cardiac PET in patients receiving Ranolazine versus control


Current Secondary Outcome:

Original Secondary Outcome: SAQ Scores [ Time Frame: 4 weeks ]

Determine if Ranolazine changes SAQ scores in association with changes in CFR versus controls.


Information By: Yale University

Dates:
Date Received: January 30, 2014
Date Started: April 2014
Date Completion:
Last Updated: April 10, 2017
Last Verified: February 2017