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

Overview

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

Full Title of Study: “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)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 11, 2018

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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.
  • Percentage of Participants With Angina Symptoms
    • Time Frame: Up to 10 months
  • Percentage of Participants With Pathologic Echocardiography Results
    • Time Frame: 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.
  • Left Ventricular End-Diastolic Volume (LVEDV) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
    • Time Frame: 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
  • Ventricular Wall Motion in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
    • Time Frame: 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
  • Left Ventricular Ejection Fraction (LVEF) in Participants with Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
    • Time Frame: Up to 10 Months
  • Percentage of Participants Receiving Anti-ischemic Drugs
    • Time Frame: 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.
  • 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
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Merck KGaA, Darmstadt, Germany
  • Collaborator
    • Merck Serono Co., Ltd., China
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Responsible, Study Director, Merck Serono Co., Ltd, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

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