Clinical trial NCT03584321: Retrospective Study to Estimate the Current Status of Patients With Non-Obstructive coroNary Artery Disease
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Obstructive Coronary Artery Disease
Keywords: Non-Obstructive Coronary Artery Disease
Coronary Angiography
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Co., Ltd., China
First posted: 2018-07-12
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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


Eligibility 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

Primary outcomes:
measure: Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD)
timeFrame: Up to 10 Months
Secondary outcomes:
measure: Percentage of Participants With Combined Cardiovascular Risk Factors
timeFrame: Up to 10 Months
measure: Percentage of Participants With Angina Symptoms
timeFrame: Up to 10 months
measure: Percentage of Participants With Pathologic Echocardiography Results
timeFrame: Up to 10 Months
measure: Ventricular Wall thickness in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
timeFrame: Up to 10 Months
measure: Left Ventricular End-Diastolic Volume (LVEDV) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
timeFrame: Up to 10 Months
measure: Left Ventricular End Diastolic Diameter (LVEDD) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
timeFrame: Up to 10 Months
measure: Ventricular Wall Motion in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
timeFrame: Up to 10 Months
measure: 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)
timeFrame: Up to 10 Months
measure: Left Ventricular Ejection Fraction (LVEF) in Participants with Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
timeFrame: Up to 10 Months
measure: Percentage of Participants Receiving Anti-ischemic Drugs
timeFrame: Up to 10 Months
measure: Percentage of Participants with Myocardial Event Prevention
timeFrame: Up to 10 Months
measure: Percentage of Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) Segregated by Age Groups, Genders, Races and Provinces
timeFrame: Up to 10 Months
measure: Correlation Coefficient Between Participants With Non-obstructive CAD confirmed by CAG and Clinical Characteristics
timeFrame: Up to 10 Months
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Please Contact the Merck KGaA Communication Center
Study officials:
affiliation: Merck Serono Co., Ltd, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: