Retrospective Study to Estimate the Current Status of Patients With Non-Obstructive coroNary Artery Disease
RESPOND
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)
1 other identifier
observational
1,600
1 country
1
Brief Summary
The study will estimate the current status of participants with non-obstructive coronary artery disease confirmed via coronary angiography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2017
CompletedFirst Submitted
Initial submission to the registry
June 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 12, 2018
CompletedOctober 30, 2018
October 1, 2018
10 months
June 29, 2018
October 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD)
Up to 10 Months
Secondary Outcomes (13)
Percentage of Participants With Combined Cardiovascular Risk Factors
Up to 10 Months
Percentage of Participants With Angina Symptoms
Up to 10 months
Percentage of Participants With Pathologic Echocardiography Results
Up to 10 Months
Ventricular Wall thickness in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
Up to 10 Months
Left Ventricular End-Diastolic Volume (LVEDV) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
Up to 10 Months
- +8 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- Participants who had typical or atypical angina symptom before Coronary Angiography examination
- Underwent CAG between 01 Jan 2013 and 31 Dec 2015
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck KGaA, Darmstadt, Germanylead
- Merck Serono Co., Ltd., Chinacollaborator
Study Sites (1)
Please Contact the Merck KGaA Communication Center
Darmstadt, 64293, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck Serono Co., Ltd, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2018
First Posted
July 12, 2018
Study Start
September 13, 2017
Primary Completion
July 11, 2018
Study Completion
July 11, 2018
Last Updated
October 30, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share