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

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ClinicalTrials.gov Identifier: NCT03584321
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
Merck Serono Co., Ltd., China
Information provided by (Responsible Party):
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.

Condition or disease
Non-Obstructive Coronary Artery Disease

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Study Type : Observational
Actual Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Actual Study Start Date : September 13, 2017
Actual Primary Completion Date : July 11, 2018
Actual Study Completion Date : July 11, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD) [ Time Frame: Up to 10 Months ]

Secondary Outcome Measures :
  1. 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.

  2. Percentage of Participants With Angina Symptoms [ Time Frame: Up to 10 months ]
  3. Percentage of Participants With Pathologic Echocardiography Results [ Time Frame: Up to 10 Months ]
  4. 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.

  5. Left Ventricular End-Diastolic Volume (LVEDV) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) [ Time Frame: Up to 10 Months ]
  6. Left Ventricular End Diastolic Diameter (LVEDD) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) [ Time Frame: Up to 10 Months ]
  7. Ventricular Wall Motion in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) [ Time Frame: Up to 10 Months ]
  8. 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 ]
  9. Left Ventricular Ejection Fraction (LVEF) in Participants with Obstructive and Non-Obstructive Coronary Artery Disease (CAD) [ Time Frame: Up to 10 Months ]
  10. Percentage of Participants Receiving Anti-ischemic Drugs [ Time Frame: Up to 10 Months ]
  11. 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.

  12. 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 ]
  13. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584321


Locations
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Germany
Please Contact the Merck KGaA Communication Center
Darmstadt, Germany, 64293
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Merck Serono Co., Ltd., China
Investigators
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Study Director: Medical Responsible Merck Serono Co., Ltd, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT03584321     History of Changes
Other Study ID Numbers: MS200101_0003
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Merck KGaA, Darmstadt, Germany:
Non-Obstructive Coronary Artery Disease
Coronary Angiography

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases