Microvascular Coronary Artery DiseasePRINCIPENCT04560829
Additive Value of Physiology Coronary in Clinical Practice
An observational study of Microvascular Coronary Artery Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The important evidence of coronary microcirculation for the management of patients with coronary artery disease is only increasing. Thus, in recent years, a number of studies have shown that the demonstration of coronary microvascular disease (CMVD) contributes to cardiovascular morbidity and mortality increases… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microvascular Coronary Artery Disease
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2021to May 2023
- How long will I take part?
- 12 Months
- 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: Any patient undergoing coronary artery assessment. Patients will be included in the study prospectively during the assessment with collection of the patient's non-objection during follow-ups.
Who may be able to join
- Male or female patients over 18 years of age
- Having a coronary angiography
- Presenting in pain or having performed a positive ischemia test
- Affiliated with social security
- Non-opposition to participation
Who cannot join
- Adult patient protected by law (article L1121-8)
- Person deprived of liberty (article L1121-8)
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
La Tronche, 38700
Clémence charlon, 0476766652, ccharlon@chu-grenoble.fr
About this study
The important evidence of coronary microcirculation for the management of patients with coronary artery disease is only increasing. Thus, in recent years, a number of studies have shown that the demonstration of coronary microvascular disease (CMVD) contributes to cardiovascular morbidity and mortality increases independently of epicardial damage. This has been shown in stable coronary artery disease with screening for CMVD when there is no significant epicardial involvement and allowing the implementation of an adapted treatment then reducing the symptoms and improving the quality of life of our patients. (1). The prognostic nature of CMVD has also been identified in stable disease after coronary angioplasty (2) but also in patients with infarcts reperfused by coronary angioplasty (3).
The complete exploration of the epicardial and microvascular coronary vascularization is grouped under the name of the subspecialty: coronary physiology. Thus, an internationally recognized algorithm for exploring coronary physiology has been published (4).
However, this algorithm is still little followed. The PRINCIPE registry aims to assess the prevalence of CMVD with the use of a standardized algorithm for exploring coronary physiology by coronary angiography in our center in current practice.
- Conditions
- Microvascular Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CMVD defined by microcirculatory resistance index (IMR) > 25
Measured: At inclusion
Secondary outcomes (11)
Prevalence of macro and microvascular angina
Macro and microvascular angina rate according to international angiographic diagnostic criteria
Measured: At inclusion
Correlation between coronary physiology parameters and imaging data
Coronary angiography and coronary physiology parameters:% of epicardial stenosis, FFR, CFR, IMR
Measured: At inclusion
Correlation between coronary physiology parameters and imaging data
SPEC parameters
Measured: At inclusion
Correlation between coronary physiology parameters and imaging data
Cardiac echography parameters
Measured: At inclusion
Correlation between coronary physiology parameters and imaging data
Stress cardiac echography parameters
Measured: At inclusion
Correlation between coronary physiology parameters and imaging data
MRI parameters
Measured: At inclusion
Correlation between coronary physiology parameters and imaging data
Cardiac CT parameters
Measured: At inclusion
Assessment of the symptoms of angina pectoris
Brief angina questionnaire
Measured: 12 months
Compare the rate of peri-procedural myocardial distress
Post PCI troponin rate
Measured: At inclusion
Evaluate medical consumption
Number of medical consultation
Measured: 12 months
Evaluation of serious cardiovascular event rate
Cardiovascular event
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start13 Sep 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560829
- Sponsor's protocol ID
- 38RC20.294
- Other IDs
- 2020-A02325-34
- Acronym
- PRINCIPE
- Status last verified
- May 2022
- First submitted
- 17 Sep 2020
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Value of Physiology Coronary in Clinical Practice
- ClinicalTrials.gov ID
- NCT04560829
- Acronym / sponsor ID
- PRINCIPE / 38RC20.294
- Conditions
- Microvascular Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 23 Sep 2020 (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 important evidence of coronary microcirculation for the management of patients with coronary artery disease is only increasing. Thus, in recent years, a number of studies have shown that the demonstration of coronary microvascular disease (CMVD) contributes to cardiovascular morbidity and mortality increases independently of epicardial damage. This has been shown in stable coronary artery disease with screening for CMVD when there is no significant epicardial involvement and allowing the implementation of an adapted treatment then reducing the symptoms and improving the quality of life of our patients. (1). The prognostic nature of CMVD has also been identified in stable disease after coronary angioplasty (2) but also in patients with infarcts reperfused by coronary angioplasty (3).
The complete exploration of the epicardial and microvascular coronary vascularization is grouped under the name of the subspecialty: coronary physiology. Thus, an internationally recognized algorithm for exploring coronary physiology has been published (4).
However, this algorithm is still little followed. The PRINCIPE registry aims to assess the prevalence of CMVD with the use of a standardized algorithm for exploring coronary physiology by coronary angiography in our center in current practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any patient undergoing coronary artery assessment. Patients will be included in the study prospectively during the assessment with collection of the patient's non-objection during follow-ups.
Key inclusion criteria (5 listed)
- Male or female patients over 18 years of age
- Having a coronary angiography
- Presenting in pain or having performed a positive ischemia test
- Affiliated with social security
- Non-opposition to participation
Key exclusion criteria (3 listed)
- Adult patient protected by law (article L1121-8)
- Person deprived of liberty (article L1121-8)
- Pregnant woman
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
Rate of CMVD defined by microcirculatory resistance index (IMR) > 25
Time frame: At inclusion
11 secondary outcomes
Prevalence of macro and microvascular angina
Time frame: At inclusion
Correlation between coronary physiology parameters and imaging data
Time frame: At inclusion
Correlation between coronary physiology parameters and imaging data
Time frame: At inclusion
Correlation between coronary physiology parameters and imaging data
Time frame: At inclusion
Correlation between coronary physiology parameters and imaging data
Time frame: At inclusion
Correlation between coronary physiology parameters and imaging data
Time frame: At inclusion
Correlation between coronary physiology parameters and imaging data
Time frame: At inclusion
Assessment of the symptoms of angina pectoris
Time frame: 12 months
Compare the rate of peri-procedural myocardial distress
Time frame: At inclusion
Evaluate medical consumption
Time frame: 12 months
Evaluation of serious cardiovascular event rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Microvascular Coronary Artery Disease, run by University Hospital, Grenoble at 1 site in France.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 May 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles Barone Rochette, MD PhD (+33476768888, gbarone@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CMVD defined by microcirculatory resistance index (IMR) > 25 (time frame: At inclusion). 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 25 May 2022.