Retrospective Study to Estimate the Current Status of Patients With Non-Obstructive coroNary Artery Disease

Completed

• Conditions: Non-Obstructive Coronary Artery Disease

• Registration Number: NCT03584321
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-13
• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-06-29
• Primary Completion: 2018-07-11
• Study Completion: 2018-07-11
• Study First Posted: 2018-07-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD)	Up to 10 Months

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Combined Cardiovascular Risk Factors	Up to 10 Months	Combined cardiovascular risk factors include: body mass index, smoking habit, hypertension, hyperlipidemia diabetes mellitus, lack of exercise, alcohol intake and family history of early onset cardiovascular disease. Percentage of participants with combined cardiovascular risk factors will be reported.
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	Mean left ventricular posterior wall thickness (LVPW), interventricular septum (IVS) thickness, other ventricular wall thickness will be assessed for the participants with obstructive and non-obstructive CAD.
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 achieving event prevention by antiplatelet agent, anticoagulants, β-blockers, Angiotensin converting enzyme inhibitor (ACEI), Angiotensin receptor blocker (ARB), statin, aldosterone antagonist will be reported.
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	Correlation coefficient between the participants with non-obstructive CAD and different clinical characteristics like demographic characteristics, combined cardiovascular risk factors and angina symptoms will be assessed using logistic regression analysis.

Trial Locations

Locations (1)

Please Contact the Merck KGaA Communication Center; 🇩🇪 Darmstadt, Germany