Non-Obstructive Coronary Artery DiseaseRESPONDNCT03584321
Retrospective Study to Estimate the Current Status of Patients With Non-Obstructive coroNary Artery Disease
An observational study of Non-Obstructive Coronary Artery Disease, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial summary
The study will estimate the current status of participants with non-obstructive coronary artery disease confirmed via coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Obstructive Coronary Artery Disease
- How many people
- 1,600 participants
- Where
- 1 siteGermany
- Study dates
- 13 Sep 2017to 11 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Please Contact the Merck KGaA Communication Center
Darmstadt, 64293
About this study
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)
The study will estimate the current status of participants with non-obstructive coronary artery disease confirmed via coronary angiography.
- Conditions
- Non-Obstructive Coronary Artery Disease
- Keywords
- Non-Obstructive Coronary Artery Disease, Coronary Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD)
Measured: Up to 10 Months
Secondary outcomes (13)
Percentage of Participants With Combined Cardiovascular Risk Factors
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.
Measured: Up to 10 Months
Percentage of Participants With Angina Symptoms
Measured: Up to 10 months
Percentage of Participants With Pathologic Echocardiography Results
Measured: Up to 10 Months
Ventricular Wall thickness in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
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.
Measured: Up to 10 Months
Left Ventricular End-Diastolic Volume (LVEDV) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
Measured: Up to 10 Months
Left Ventricular End Diastolic Diameter (LVEDD) in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
Measured: Up to 10 Months
Ventricular Wall Motion in Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
Measured: 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)
Measured: Up to 10 Months
Left Ventricular Ejection Fraction (LVEF) in Participants with Obstructive and Non-Obstructive Coronary Artery Disease (CAD)
Measured: Up to 10 Months
Percentage of Participants Receiving Anti-ischemic Drugs
Measured: Up to 10 Months
Percentage of Participants with Myocardial Event Prevention
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.
Measured: Up to 10 Months
Percentage of Participants With Obstructive and Non-Obstructive Coronary Artery Disease (CAD) Segregated by Age Groups, Genders, Races and Provinces
Measured: Up to 10 Months
Correlation Coefficient Between Participants With Non-obstructive CAD confirmed by CAG and Clinical Characteristics
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.
Measured: Up to 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start13 Sep 2017
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Obstructive Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Co., Ltd., China
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Serono Co., Ltd, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584321
- Sponsor's protocol ID
- MS200101_0003
- Acronym
- RESPOND
- Status last verified
- Oct 2018
- First submitted
- 29 Jun 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03584321
- Acronym / sponsor ID
- RESPOND / MS200101_0003
- Conditions
- Non-Obstructive Coronary Artery Disease
- Keywords
- Non-Obstructive Coronary Artery Disease, Coronary Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Co., Ltd., China
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will estimate the current status of participants with non-obstructive coronary artery disease confirmed via coronary angiography.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD)
Time frame: Up to 10 Months
13 secondary outcomes
Percentage of Participants With Combined Cardiovascular Risk Factors
Time frame: Up to 10 Months
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
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Serono Co., Ltd, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Obstructive Coronary Artery Disease, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Non-Obstructive Coronary Artery Disease (CAD) (time frame: Up to 10 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.