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

October 29, 2018 updated by: Merck KGaA, Darmstadt, Germany

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)

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

Study Overview

Status

Completed

Conditions

Non-Obstructive Coronary Artery Disease

Study Type

Observational

Enrollment (Actual)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Darmstadt, Germany, 64293
    - Please contact the Merck KGaA Communication Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants who were suspected or had confirmed coronary artery disease and who underwent coronary angiography between 01 Jan 2013 and 31 Dec 2015 will be observed in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Retrospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Participants with Coronary Artery Disease Participants with suspected or confirmed coronary artery disease who underwent coronary angiography during 01 Jan 2013 and 31 Dec 2015 will be observed in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD) Time Frame: Up to 10 Months	Up to 10 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Combined Cardiovascular Risk Factors Time Frame: 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.	Up to 10 Months
Percentage of Participants With Angina Symptoms Time Frame: Up to 10 months		Up to 10 months
Percentage of Participants With Pathologic Echocardiography Results Time Frame: Up to 10 Months		Up to 10 Months
Ventricular Wall thickness in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) Time Frame: 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.	Up to 10 Months
Left Ventricular End-Diastolic Volume (LVEDV) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) Time Frame: Up to 10 Months		Up to 10 Months
Left Ventricular End Diastolic Diameter (LVEDD) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) Time Frame: Up to 10 Months		Up to 10 Months
Ventricular Wall Motion in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) Time Frame: Up to 10 Months		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) Time Frame: Up to 10 Months		Up to 10 Months
Left Ventricular Ejection Fraction (LVEF) in Participants with Obstructive and Non-Obstructive Coronary Artery Disease (CAD) Time Frame: Up to 10 Months		Up to 10 Months
Percentage of Participants Receiving Anti-ischemic Drugs Time Frame: Up to 10 Months		Up to 10 Months
Percentage of Participants with Myocardial Event Prevention Time Frame: 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.	Up to 10 Months
Percentage of Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) Segregated by Age Groups, Genders, Races and Provinces Time Frame: Up to 10 Months		Up to 10 Months
Correlation Coefficient Between Participants With Non-obstructive CAD confirmed by CAG and Clinical Characteristics Time Frame: 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.	Up to 10 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono Co., Ltd., China

Investigators

Study Director: Medical Responsible, Merck Serono Co., Ltd, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2017

Primary Completion (Actual)

July 11, 2018

Study Completion (Actual)

July 11, 2018

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria