A Multi-center, Retrospective, Registry Study to Estimate the Current Status of Patients With Non-Obstructive coroNary Artery Disease (CAD) Confirmed Via Coronary Angiography (CAG) (RESPOND Study)

Merck KGaA, Darmstadt, Germany1 site in 1 country1,600 target enrollmentSeptember 13, 2017

ConditionsNon-Obstructive Coronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-Obstructive Coronary Artery Disease
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 1600
Locations: 1
Primary Endpoint: Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study will estimate the current status of participants with non-obstructive coronary artery disease confirmed via coronary angiography.

Registry

clinicaltrials.gov

Start Date

September 13, 2017

End Date

July 11, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants who had typical or atypical angina symptom before Coronary Angiography examination
•Underwent CAG between 01 Jan 2013 and 31 Dec 2015
•Other protocol defined inclusion criteria could apply

Exclusion Criteria

•Participant with history of percutaneous coronary intervention or coronary artery bypass surgery
•Participant with history of myocardial infarction
•Participant with history of cardiac transplant or valve surgery
•Presenting with Acute myocardial infarction for coronary angiography
•CAG showed myocardial bridge and coronary stenosis greater than or equal to 50 percent during systole period
•Incomplete or missing data in CAG report
•Other protocol defined exclusion criteria could apply

Outcomes

Primary Outcomes

Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD)

Time Frame: Up to 10 Months

Secondary Outcomes

Percentage of Participants With Combined Cardiovascular Risk Factors(Up to 10 Months)
Percentage of Participants With Angina Symptoms(Up to 10 months)
Percentage of Participants With Pathologic Echocardiography Results(Up to 10 Months)
Ventricular Wall thickness in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)(Up to 10 Months)
Left Ventricular End-Diastolic Volume (LVEDV) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)(Up to 10 Months)
Left Ventricular End Diastolic Diameter (LVEDD) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)(Up to 10 Months)
Ventricular Wall Motion in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)(Up to 10 Months)
Ratio of Early Trans-Mitral Flow (E) and Late Trans-Mitral Flow by Atrial Contraction (A) in Participants with Obstructive and Non-Obstructive Coronary Artery Disease (CAD)(Up to 10 Months)
Left Ventricular Ejection Fraction (LVEF) in Participants with Obstructive and Non-Obstructive Coronary Artery Disease (CAD)(Up to 10 Months)
Percentage of Participants Receiving Anti-ischemic Drugs(Up to 10 Months)
Percentage of Participants with Myocardial Event Prevention(Up to 10 Months)
Percentage of Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) Segregated by Age Groups, Genders, Races and Provinces(Up to 10 Months)
Correlation Coefficient Between Participants With Non-obstructive CAD confirmed by CAG and Clinical Characteristics(Up to 10 Months)