Coronary Artery DiseasePRV-KORONCT02404948
PRV-based Detection of CAD in Comparison to Standard Methods
An observational study of Coronary Artery Disease, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
This is a validation study comparing a pulse wave based algorithm for the detection of coronary artery disease with parameters from coronary angiography, echocardiography and cardiogoniometry. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Diagnostic algorithm
- How many people
- 156 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Jun 2017
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects referred to first coronary angiography due to suspected CAD
Who may be able to join
- Coronary angiography indication present
- informed written consent
Who cannot join
- Previous coronary angiography
- Known CAD (history of coronary angioplasty, stent implantation and/or bypass surgery)
- atrial fibrillation (at time of measurement)
- severe ventricular extrasystole (e.g. >=10% ventricular extrasystoles, bigemina)
- pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Pulse Wave Based Approach for Detection of Coronary Artery Disease Compared to Standard Methods
This is a validation study comparing a pulse wave based algorithm for the detection of coronary artery disease with parameters from coronary angiography, echocardiography and cardiogoniometry.
Read the detailed description
The study will validate a pulse wave based algorithm for the detection of coronary artery disease (CAD) with parameters from standard methods. Subjects will be patients admitted to coronary angiography due to suspected CAD. Pulse wave signals will be analyzed according to novelly established algorithm regarding the presence of CAD and/or myocardial ischemia. These results be compared to the diagnoses made by coronary angiography (primary endpoint): presence of minimum one coronary artery stenose >=50%. For secondary analyses, results will be compared to parameters form echocardiography and cardiogoniometry.
- Conditions
- Coronary Artery Disease
- Being tested
- Diagnostic algorithm
- Keywords
- coronary artery disease, diagnosis, non-invasive
- Medical subject headings
- Coronary Artery Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic algorithmOther
Validation of a diagnostic algorithm used to detect coronary artery disease and/or myocardial ischemia based on pulse wave analyses.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of CAD - angio (minimum 1 stenosis >=50%)
Presence of CAD in coronary angiography: minimum 1 stenosis >=50%
Measured: 1 day
Secondary outcomes (5)
Presence of CAD number - angio (Number of coronary vessels with at least 1 stenosis >=50% in coronary angiography)
Number of coronary vessels with at least 1 stenosis >=50% in coronary angiography
Measured: 1 day
Wall motion abnormality - echo (Presence of wall motion abnormality in at least 1 segment (2D echocardiography)
Presence of wall motion abnormality in at least 1 segment (2D echocardiography)
Measured: 1 day
Wall motion index - echo (Wall motion index (2D and 3D echocardiography)
Wall motion index (2D and 3D echocardiography)
Measured: 1 day
Global longitudinal strain (2D and 3D echocardiography)
Global longitudinal strain (2D and 3D echocardiography)
Measured: 1 day
Abnormal cardiogoniometry
Abnormal results of cardiogoniometry
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Doerr, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404948
- Sponsor's protocol ID
- PRV-Koro-Study-001
- Acronym
- PRV-KORO
- Status last verified
- Jun 2018
- First submitted
- 23 Mar 2015
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Pulse Wave Based Approach for Detection of Coronary Artery Disease Compared to Standard Methods
- ClinicalTrials.gov ID
- NCT02404948
- Acronym / sponsor ID
- PRV-KORO / PRV-Koro-Study-001
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, diagnosis, non-invasive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 1 Apr 2015 (estimated)
- 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.
This is a validation study comparing a pulse wave based algorithm for the detection of coronary artery disease with parameters from coronary angiography, echocardiography and cardiogoniometry.
Detailed description
The study will validate a pulse wave based algorithm for the detection of coronary artery disease (CAD) with parameters from standard methods. Subjects will be patients admitted to coronary angiography due to suspected CAD. Pulse wave signals will be analyzed according to novelly established algorithm regarding the presence of CAD and/or myocardial ischemia. These results be compared to the diagnoses made by coronary angiography (primary endpoint): presence of minimum one coronary artery stenose >=50%. For secondary analyses, results will be compared to parameters form echocardiography and cardiogoniometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred to first coronary angiography due to suspected CAD
Key inclusion criteria (2 listed)
- Coronary angiography indication present
- informed written consent
Key exclusion criteria (5 listed)
- Previous coronary angiography
- Known CAD (history of coronary angioplasty, stent implantation and/or bypass surgery)
- atrial fibrillation (at time of measurement)
- severe ventricular extrasystole (e.g. >=10% ventricular extrasystoles, bigemina)
- pregnancy, lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic algorithmValidation of a diagnostic algorithm used to detect coronary artery disease and/or myocardial ischemia based on pulse wave analyses. | Other | – |
Primary outcome
Presence of CAD - angio (minimum 1 stenosis >=50%)
Time frame: 1 day
Presence of CAD in coronary angiography: minimum 1 stenosis >=50%
5 secondary outcomes
Presence of CAD number - angio (Number of coronary vessels with at least 1 stenosis >=50% in coronary angiography)
Time frame: 1 day
Wall motion abnormality - echo (Presence of wall motion abnormality in at least 1 segment (2D echocardiography)
Time frame: 1 day
Wall motion index - echo (Wall motion index (2D and 3D echocardiography)
Time frame: 1 day
Global longitudinal strain (2D and 3D echocardiography)
Time frame: 1 day
Abnormal cardiogoniometry
Time frame: 1 day
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 3 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Artery Disease, run by University Medicine Greifswald 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 2 inclusion and 5 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 3 Jul 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?
Presence of CAD - angio (minimum 1 stenosis >=50%) (time frame: 1 day). 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 3 Jul 2018.