Ranolazine and Microvascular Angina by PET in the Emergency Department

Microvascular Angina Clinical Trial

— RAMP-ED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052011
• Other study ID #: 1312013144
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2014
• Last updated: September 6, 2016
• Start date: April 2014
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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'.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted to the Yale ED CPC

• = 30 years age

• chest pain or angina equivalent as their chief complaint within 24 hours of enrollment

• Coronary Flow Reserve(CFR) <2.5 on PET scan in the ED.

Exclusion Criteria:

• Acute coronary syndrome

• Prior evidence of obstructive heart disease (history of Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery Bypass Grafting (CABG) or calcium score > 10 on PET scan)

• Resting blood pressure of systolic >180/110 mm Hg or <100/40

• known cardiomyopathy or heart failure

• currently on dialysis

• creatinine clearance <30 ml/min

• liver cirrhosis

• significant aortic stenosis (murmur on exam)

• active use of cocaine or amphetamine

• current use of potent CYP3A4 inducers or inhibitors (such as ketoconazole, clarithromycin, HIV protease inhibitors)

• baseline QTc > 580 msec

• use of drugs that prolong QTc (Haldol, erythromycin)

• pregnancy

• inability to read or understand English

• suffering from a condition that precludes interview (i.e. cognitive or communication impairment).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Emergencies
• Microvascular Angina

Intervention

Drug:
• Ranolazine
Subjects will take the extended-release Ranolazine for a total of 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
• Placebo

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Return Visits	Compare the composite rates of return visits (office, emergency department and hospitalization) for ches pain within 4 weeks of enrollment between patients with and without Ranolazine.	4 weeks	No
Primary	Coronary Flow Reserve	Compare changes in coronary flow reserve as measured by cardiac PET(Positron Emission Tomography) in patients receiving Ranolazine versus control	4 weeks	No
Secondary	SAQ(Seattle Angina Questionnaire) Scores	Determine if Ranolazine changes SAQ(Seattle Angina Questionnaire) scores in association with changes in CFR(Coronary Flow Reserve) versus controls.	4 weeks	No