An Interventional, Pilot Study to Evaluate the Efficacy of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive CAD Patients (SPET Study)

Merck KGaA, Darmstadt, Germany1 site in 1 country8 target enrollmentNovember 30, 2016

ConditionsNon-obstructive Coronary Artery Disease

InterventionsNicorandil

DrugsNicorandil

Overview

Phase: Phase 4
Intervention: Nicorandil
Conditions: Non-obstructive Coronary Artery Disease
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 8
Locations: 1
Primary Endpoint: Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a single-center, interventional, pilot study to evaluate the improvement of microvascular function by positron emission tomography (PET) after twelve-week treatment of oral nicorandil in female non-obstructive CAD Participants.

Registry

clinicaltrials.gov

Start Date

November 30, 2016

End Date

July 9, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Nicorandil

Intervention: Nicorandil

Outcomes

Primary Outcomes

Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12

Time Frame: Baseline, Week 12

Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.

Secondary Outcomes

Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12(Baseline, Week 12)
Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12(Baseline, Week 12)
Change From Baseline in Ejection Fraction at Week 12(Baseline, Week 12)
Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12(Baseline, Week 12)
Change From Baseline in Left Ventricular Wall Thickness at Week 12(Baseline, Week 12)
Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12(Baseline, Week 12)
Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12(Baseline, Week 12)