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Completed

NCT Number: NCT03584321

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

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

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Key information

Conditions

Non-Obstructive Coronary Artery Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Please Contact the Merck KGaA Communication Center

Darmstadt, 64293, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD)

    Time frame: Up to 10 Months

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono Co., Ltd., China

Registry information

Official study 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)

Acronym: RESPOND

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 12, 2018
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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