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

Non-Obstructive Coronary Artery Disease Clinical Trial

— RESPOND  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584321
• Other study ID #: MS200101_0003
• Status: Completed
• Start date: September 13, 2017
• Est. completion date: July 11, 2018

Study information

• Verified date: October 2018
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: July 11, 2018
• Est. primary completion date: July 11, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Non-Obstructive Coronary Artery Disease

Locations

Country	Name	City	State
Germany	Please Contact the Merck KGaA Communication Center	Darmstadt

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono Co., Ltd., China

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD)		Up to 10 Months
Secondary	Percentage of Participants With Combined Cardiovascular Risk Factors	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.	Up to 10 Months
Secondary	Percentage of Participants With Angina Symptoms		Up to 10 months
Secondary	Percentage of Participants With Pathologic Echocardiography Results		Up to 10 Months
Secondary	Ventricular Wall thickness in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)	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.	Up to 10 Months
Secondary	Left Ventricular End-Diastolic Volume (LVEDV) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)		Up to 10 Months
Secondary	Left Ventricular End Diastolic Diameter (LVEDD) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)		Up to 10 Months
Secondary	Ventricular Wall Motion in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)		Up to 10 Months
Secondary	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
Secondary	Left Ventricular Ejection Fraction (LVEF) in Participants with Obstructive and Non-Obstructive Coronary Artery Disease (CAD)		Up to 10 Months
Secondary	Percentage of Participants Receiving Anti-ischemic Drugs		Up to 10 Months
Secondary	Percentage of Participants with Myocardial Event Prevention	Percentage of participants achieving event prevention by antiplatelet agent, anticoagulants, ß-blockers, Angiotensin converting enzyme inhibitor (ACEI), Angiotensin receptor blocker (ARB), statin, aldosterone antagonist will be reported.	Up to 10 Months
Secondary	Percentage of Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) Segregated by Age Groups, Genders, Races and Provinces		Up to 10 Months
Secondary	Correlation Coefficient Between Participants With Non-obstructive CAD confirmed by CAG and Clinical Characteristics	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.	Up to 10 Months