Coronary Microvascular DiseaseDECISIONINGNCT05178914
Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina
A study testing Treatment adaptation in people with Coronary Microvascular Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The evidence demonstrating the importance of coronary microcirculation in the management of patients with coronary artery disease is growing. For example, in recent years, a number of studies have demonstrated that the presence of coronary microvascular disease (CMVD) contributes to increased cardiovascular morbidity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Disease
- What is being tested?
- Treatment adaptation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2022to Mar 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years
- Symptomatology of angina pectoris
- Receiving invasive coronary angiography
- FFR and microcirculatory resistance index (MRI) measurement for at least one epicardial lesion ≥ 50% :
- For lesions with FFR ≤ 0.8, revascularization with the XIENCE Sierra stent and its evolutions will be performed. Optimization of this epicardial revascularization will be evidenced by a post-PCI FFR > 0.8 on all major trunks and if an FFR measurement is not performed, absence of 50% or greater stenosis on two orthogonal views by quantitative coronary angiography [QCA] at the revascularization site.
- For lesions with FFR > 0.8 revascularization will not be performed
- Written informed consent
Who cannot join
- A non-coronary indication for coronary angiography, e.g. valve disease, hypertrophic obstructive cardiomyopathy.
- Severe renal dysfunction (GFR < 30 ml/min)
- Contraindications for adenosine: asthma, Second or third degree AV block without pacemaker or sick sinus syndrome, Systolic blood pressure less than 90 mm Hg, Recent use of dipyridamole or drugs containing dipyridamole, Methyl xanthenes such as caffeine aminophylline or theobromine block the effect of adenosine and should be stored at least 12 hours before testing, Known hypersensitivity to adenosine.
- Pregnant women, parturients and breastfeeding mothers
- Persons of full age who are subject to a legal protection measure or who are unable to express their consent
- Patient in a period of exclusion from another study
- Patient under administrative or judicial supervision
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
La Tronche, 38700
Gille Barone Rochette, PI, 0476765172, gbarone@chu-grenoble.fr
About this study
The evidence demonstrating the importance of coronary microcirculation in the management of patients with coronary artery disease is growing. For example, in recent years, a number of studies have demonstrated that the presence of coronary microvascular disease (CMVD) contributes to increased cardiovascular morbidity and mortality independent of the extent and severity of coronary epicardial disease. The index of microcirculatory resistance (IMR) is an invasive index proposed for the diagnosis of CMVD. The ability of IMR to motivate therapeutic changes in order to subsequently reduce symptoms and improves the quality of life of our patients with stable coronary artery disease (CAD) was recently demonstrated. The prognostic value of IMR has also been shown in stable CAD with PCI. Thus, after optimal epicardial evaluation and if necessary revascularization according to FFR, IMR could represent a tool for personalized medicine adapted to the presence of severe CMVD.
The aim of the study is to demonstrate a positive effect of personalized medicine on angina in patients with epicardial coronary network lesion assessment by FFR and with significant CMVD assessed by IMR.
- Conditions
- Coronary Microvascular Disease
- Being tested
- Treatment adaptation
- Keywords
- index of microcirculatory resistance
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment adaptationProcedure or surgery
Patients will benefit from intensified treatment or de escalation treatment according to the result of the index of microcirculatory resistance
| Study group | Role | What they receive |
|---|---|---|
| The interventional group | Experimental | Patients are defined by the disclosure of the IMR value. The initial IMR is used to guide therapy.
For patients with initial IMR ≥ 25 will benefit from intensified coronary artery disease treatment to manage the microcirculatory damage according to the recommendations and consensus of European experts.
For patients with a initial IMR < 25 will benefit from de-escalade therapeutic adaptation. Receives: Procedure: Treatment adaptation |
| The control group | Sham comparator | The control group is defined as follows: the initial IMR has been performed but its result is not undisclosed (sham procedure) ; patients will receive standard medical treatment according to the physician's preference. Receives: Procedure: Treatment adaptation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference in angina severity
Assessed by the Seattle Angina Questionnaire summary score) between patients with an IMR ≥ 25 in the interventional group, benefiting from personalized medicine, and patients with IMR ≥ 25 in the control group benefiting from standard care
Measured: One year
Secondary outcomes (11)
To demonstrate a positive effect of personalized medicine guided by IMR assessment on physical limitation due to angina
The physical limitation scale is assessed by question 1 of the Seattle Angina questionnaire and measures how daily activities are limited by symptoms of coronary disease.
This question includes 9 sub-questions with 5 possible answers from the worse to the best.
The analysis will be performed between :
- IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group
- IMR < 25 in the interventional group versus patients with an IMR < 25 in the control group
Measured: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on stability of angina
The angina stability scale is assessed by question 2 of the Seattle Angina Questionnaire and measures change in the frequency of angina at patient's most streneous level of activity.
There are 5 possible answers from the worse to the best.
The analysis will be performed between :
- IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group
- IMR < 25 in the interventional group versus patients with an IMR < 25 in the control group
Measured: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on frequency of angina
The angina frequency scale is assessed by question 3 and 4 of the Seattle Angina questionaire. It measures the frequency of angina (question 3) and the need of nitroglycerin (question 4) For each question, there are 5 possible answers from the worse to the best.
The analysis will be performed between :
- IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group
- IMR < 25 in the interventional group versus patients with an IMR < 25 in the control group
Measured: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on perception of the disease.
Perception of illness will be analyzed by questions 9-11 of the Seattle Angina questionnaire and characterizes the illness-related burden experienced by the patient.
The analysis will be performed between :
- IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group
- IMR < 25 in the interventional group versus patients with an IMR < 25 in the control group
Measured: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment with satisfaction with the treatment.
Satisfaction with the treatment is assessed by questions 5 to 8 of the Seattle Angina Questionnaire and quantifies patient's satisfaction with their current treatment.
The analysis will be performed between :
- IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group
- IMR < 25 in the interventional group versus patients with an IMR < 25 in the control group
Measured: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR on assessment of dyspnea.
The assessment of dyspnea will be evaluated by the Rose Dyspnea Scale, a 4-part questionnaire.
The analysis will be performed between :
- IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group
- IMR < 25 in the interventional group versus patients with an IMR < 25 in the control group
Measured: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on quality of life.
The assessment on quality of life will be evaluated by the EQ5D-5L, a 5-part questionnaire.
The analysis will be performed between :
- IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group
- IMR < 25 in the interventional group versus patients with an IMR < 25 in the control group
Measured: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on health care consumption.
Health care consumption will be assessed by the number and relative cost of consultations with a general practitioner, cardiologist or other specialist; as well as the number of imaging tests performed. These examinations will be collected by self-reporting at the time of follow-up visits.
The analysis will be performed between :
- IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group
- IMR < 25 in the interventional group versus patients with an IMR < 25 in the control group
Measured: 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on the number of Major Cardiovascular Events (MACE).
MACE will be assessed by cumulative rates in the year of death, myocardial infarction, target vessel failure, hospitalization for unstable angina, or heart failure.
The analysis will be performed between :
- IMR ≥ 25 in the interventional group versus patients with an IMR ≥ 25 in the control group
- IMR < 25 in the interventional group versus patients with an IMR < 25 in the control group
Measured: 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on the prevalence of subgroups.
The prevalence of sub-groups will be assessed by performing IMR pre and post-PCI for each patient.
Measured: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on the angina Severity according to subgroups.
The angina Severity will be assessed by The Seattle Angina Questionnaire.
The analysis will therefore be performed between subgroups as follow:
- IMR pre-PCI <25 and IMR post-PCI <25
- IMR pre-PCI <25 and IMR post-PCI ≥25
- IMR pre-PCI ≥25 and IMR post-PCI <25
- IMR pre-PCI ≥25 and IMR post-PCI ≥25
Measured: At 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start31 Mar 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with a symptomatology of angina pectoris who have at least one epicardial lesion greater than or equal to 50% on coronary angiography evaluation The interventional group is defined by the disclosure of the IMR value. The initial IMR is used to guide therapy. The control group is defined as follows: the initial IMR has been performed but its result is not undisclosed (sham procedure) ; patients will receive standard medical treatment according to the physician's preference.
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178914
- Sponsor's protocol ID
- 38RC21.0339
- Acronym
- DECISIONING
- Status last verified
- Jun 2024
- First submitted
- 20 Oct 2021
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina
- ClinicalTrials.gov ID
- NCT05178914
- Acronym / sponsor ID
- DECISIONING / 38RC21.0339
- Conditions
- Coronary Microvascular Disease
- Keywords
- index of microcirculatory resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 5 Jan 2022 (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 evidence demonstrating the importance of coronary microcirculation in the management of patients with coronary artery disease is growing. For example, in recent years, a number of studies have demonstrated that the presence of coronary microvascular disease (CMVD) contributes to increased cardiovascular morbidity and mortality independent of the extent and severity of coronary epicardial disease. The index of microcirculatory resistance (IMR) is an invasive index proposed for the diagnosis of CMVD. The ability of IMR to motivate therapeutic changes in order to subsequently reduce symptoms and improves the quality of life of our patients with stable coronary artery disease (CAD) was recently demonstrated. The prognostic value of IMR has also been shown in stable CAD with PCI. Thus, after optimal epicardial evaluation and if necessary revascularization according to FFR, IMR could represent a tool for personalized medicine adapted to the presence of severe CMVD.
The aim of the study is to demonstrate a positive effect of personalized medicine on angina in patients with epicardial coronary network lesion assessment by FFR and with significant CMVD assessed by IMR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with a symptomatology of angina pectoris who have at least one epicardial lesion greater than or equal to 50% on coronary angiography evaluation The interventional group is defined by the disclosure of the IMR value. The initial IMR is used to guide therapy. The control group is defined as follows: the initial IMR has been performed but its result is not undisclosed (sham procedure) ; patients will receive standard medical treatment according to the physician's preference.
| Arm | Type | Receives |
|---|---|---|
| The interventional group | Experimental | Procedure: Treatment adaptationPatients are defined by the disclosure of the IMR value. The initial IMR is used to guide therapy. For patients with initial IMR ≥ 25 will benefit from intensified coronary artery disease treatment to manage the microcirculatory damage according to the recommendations and consensus of European experts. For patients with a initial IMR < 25 will benefit from de-escalade therapeutic adaptation. |
| The control group | Sham comparator | Procedure: Treatment adaptationThe control group is defined as follows: the initial IMR has been performed but its result is not undisclosed (sham procedure) ; patients will receive standard medical treatment according to the physician's preference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient over 18 years
- Symptomatology of angina pectoris
- Receiving invasive coronary angiography
- FFR and microcirculatory resistance index (MRI) measurement for at least one epicardial lesion ≥ 50% :
- For lesions with FFR ≤ 0.8, revascularization with the XIENCE Sierra stent and its evolutions will be performed. Optimization of this epicardial revascularization will be evidenced by a post-PCI FFR > 0.8 on all major trunks and if an FFR measurement is not performed, absence of 50% or greater stenosis on two orthogonal views by quantitative coronary angiography [QCA] at the revascularization site.
Key exclusion criteria (7 listed)
- A non-coronary indication for coronary angiography, e.g. valve disease, hypertrophic obstructive cardiomyopathy.
- Severe renal dysfunction (GFR < 30 ml/min)
- Contraindications for adenosine: asthma, Second or third degree AV block without pacemaker or sick sinus syndrome, Systolic blood pressure less than 90 mm Hg, Recent use of dipyridamole or drugs containing dipyridamole, Methyl xanthenes such as caffeine aminophylline or theobromine block the effect of adenosine and should be stored at least 12 hours before testing, Known hypersensitivity to adenosine.
- Pregnant women, parturients and breastfeeding mothers
- Persons of full age who are subject to a legal protection measure or who are unable to express their consent
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 |
|---|---|---|
| Treatment adaptationPatients will benefit from intensified treatment or de escalation treatment according to the result of the index of microcirculatory resistance | Procedure or surgery | The control group, The interventional group |
Primary outcome
The mean difference in angina severity
Time frame: One year
Assessed by the Seattle Angina Questionnaire summary score) between patients with an IMR ≥ 25 in the interventional group, benefiting from personalized medicine, and patients with IMR ≥ 25 in the control group benefiting from standard care
11 secondary outcomes
To demonstrate a positive effect of personalized medicine guided by IMR assessment on physical limitation due to angina
Time frame: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on stability of angina
Time frame: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on frequency of angina
Time frame: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on perception of the disease.
Time frame: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment with satisfaction with the treatment.
Time frame: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR on assessment of dyspnea.
Time frame: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on quality of life.
Time frame: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on health care consumption.
Time frame: 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on the number of Major Cardiovascular Events (MACE).
Time frame: 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on the prevalence of subgroups.
Time frame: At 6 months and 1 year
To demonstrate a positive effect of personalized medicine guided by IMR assessment on the angina Severity according to subgroups.
Time frame: At 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Microvascular Angina
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?
A study testing Treatment adaptation in people with Coronary Microvascular 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 7 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. 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. Some participants in this study may receive a placebo. 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 (+33476765172, gbarone@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean difference in angina severity (time frame: One year). 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 24 Jun 2024.