Microvascular DiseaseMICRONCT04612322
MICRO: a Registry Study in Patients With Microvascular Angina
An observational study of Microvascular Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The evidence above demonstrates that microvascular dysfunction is an important determinant of patient prognosis, which however remains poorly classified. Given the high burden of disease and the severity of the functional impairment in these patients, the lack of a clear definition for this disease has a potentially… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Microvascular Disease
- What is being tested?
- Assessment of microvascular function with intracoronary hemodilution
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2020to 10 Oct 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with angina without apparent obstructive coronary artery disease (no coronary stenosis >75% at angiography) undergoing clinically-indicated assessment of coronary microvascular function.
Who may be able to join
- Age ≥ 18 and <85 years.
- Chronic coronary syndrome (including patients with anginal equivalents)
- Angina CCS class II-IV
- Evidence of reversible ischemia on non-invasive testing
- Availability of the following measurements:
- Index of microvascular resistances (IMR),
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- Resting full-cycle ratio (RFR),
- Fractional flow reserve (FFR),
- Coronary flow reserve (CFR)
- Willingness to participate and ability to understand read and signed the informed consent document before the procedure
Who cannot join
- At least one of the following:
- Pregnancy and or lactation.
- Medical or psychological conditions that would jeopardize an adequate and orderly participation.
- Left ventricular ejection fraction lower than 30%
- Previous coronary artery bypass surgery (CABG) to all major branches in the LAD and left circumflex (LCX) territory, such that IMR cannot be measured
- Decompensated congestive heart failure (CHF)
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- Chronic or acute renal failure with creatinine >2mg/dl
- Severe valvular heart disease
- Patients with comorbidities limiting life expectancy to less than one year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsmedizin Mainz
Mainz, RLP, 55131
Tommaso Gori, Dtt med, PhD, 06131176903, tommaso.gori@unimedizin-mainz.de
About this study
Official title: A Multicenter Registry on the Diagnosis of Patients With Chronic Angina and no Angiographic Coronary Artery Stenosis
The evidence above demonstrates that microvascular dysfunction is an important determinant of patient prognosis, which however remains poorly classified. Given the high burden of disease and the severity of the functional impairment in these patients, the lack of a clear definition for this disease has a potentially large clinical importance. It is important to better describe the phenotype of these patients, identify the predictors of prognosis, and determine the impact of diagnosis.
Read the detailed description
The study is designed as prospective registry. Patients with angina CCS II-IV undergoing assessment of microvascular function will be enrolled.
The study does not interfere with the medical standards at the sites with regards to patient treatment or follow-up care.
Study duration and schedule The duration of this study is expected to be 7 years. The subject recruitment is planned to start in January 2020 and end in January 2022. The actual overall study duration or subject recruitment period may differ from these time periods. Per-patient, the duration of participation will be up to 5 years. Patients will be evaluated at hospital discharge, at 12 months and 5 years (the latter two as telephone contacts).
Number of subjects and study centers It is planned to enroll 1000 subjects in the registry based on power calculations as described. Recruitment and treatment of subjects is expected to be performed in 10 study centers.
Primary endpoint The primary endpoint is the composite of cardiovascular death, myocardial infarction, rehospitalization for angina or heart failure, and unplanned coronary angiography at 12 months.
Secondary endpoints Each of the components of the primary endpoint Seattle Angina Questionnaire SAQ-7 Physical limitation scale SAQ-7 angina stability scale SAQ-7 angina frequency scale SAQ-7 angina quality of life EQ-5D-5L Beck depression inventory
The SAQ-7 "angina frequency" domain has been shown to correlate to improvements in microvascular function in the WISE study. SAQ-7-7 has been also used in a number of studies, including the ISCHEMIA study.
Other patient questionnaires are also standardized tests for the assessment of quality of life, depression and symptom severity in coronary artery disease studies.
- Conditions
- Microvascular Disease
- Being tested
- Assessment of microvascular function with intracoronary hemodilution
- Keywords
- Coronary artery disease, Angina
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of microvascular function with intracoronary hemodilutionDevice
The pressure/temperature wire allows assessing coronary flow reserve, intracoronary pressure, and coronary flow to calculate multiple parameters of coronary macro- and microvascular function.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing coronary microvascular function assessment | Not described Receives: Device: Assessment of microvascular function with intracoronary hemodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic impact of resting resistances
The impact of resting resistances (expressed as Mean Transit Time, i.e. time for a saline bolus to reach the wire thermistor times distal pressure) on the incidence of patient-oriented outcomes (composite of cardiovascular death, myocardial infarction, rehospitalization for angina or heart failure and unplanned coronary angiography) at 12 months
Measured: 12 months
Secondary outcomes (6)
Correlation between SAQ measures and IMR
Correlation of IMR with Seattle Angina Questionnaire, including each of its components (SAQ-7 Physical limitation scale, SAQ-7 angina stability scale, SAQ-7 angina frequency scale, SAQ-7 angina quality of life) at 6 months, 1 year and yearly to 5 years
Measured: 6 months, 1 year and yearly to 5 years.
Correlation between depression and IMR
Correlation of IMR with Beck depression inventory scores
Measured: 6 months, 1 year and yearly to 5 years.
Correlation between physical ability and IMR
Correlation of IMR with parameters of 5-EQ-EL
Measured: 6 months, 1 year and yearly to 5 years.
Distribution of mean transit time (Tmn)
Distribution of Tmn (seconds).
Measured: At inclusion
Distribution of index of microvascular resistances (IMR)
Distribution of IMR, units.
Measured: At inclusion
Distribution of aortic and distal pressure
Distribution of Pa (aortic pressure) and Pd (distal arterial pressure) in mmHg.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start10 Oct 2020
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Gori, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612322
- Sponsor's protocol ID
- 2020-2
- Acronym
- MICRO
- Status last verified
- Mar 2022
- First submitted
- 10 Oct 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry on the Diagnosis of Patients With Chronic Angina and no Angiographic Coronary Artery Stenosis
- ClinicalTrials.gov ID
- NCT04612322
- Acronym / sponsor ID
- MICRO / 2020-2
- Conditions
- Microvascular Disease
- Keywords
- Coronary artery disease, Angina
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Oct 2029 (estimated)
- First posted
- 2 Nov 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 evidence above demonstrates that microvascular dysfunction is an important determinant of patient prognosis, which however remains poorly classified. Given the high burden of disease and the severity of the functional impairment in these patients, the lack of a clear definition for this disease has a potentially large clinical importance. It is important to better describe the phenotype of these patients, identify the predictors of prognosis, and determine the impact of diagnosis.
Detailed description
The study is designed as prospective registry. Patients with angina CCS II-IV undergoing assessment of microvascular function will be enrolled.
The study does not interfere with the medical standards at the sites with regards to patient treatment or follow-up care.
Study duration and schedule The duration of this study is expected to be 7 years. The subject recruitment is planned to start in January 2020 and end in January 2022. The actual overall study duration or subject recruitment period may differ from these time periods. Per-patient, the duration of participation will be up to 5 years. Patients will be evaluated at hospital discharge, at 12 months and 5 years (the latter two as telephone contacts).
Number of subjects and study centers It is planned to enroll 1000 subjects in the registry based on power calculations as described. Recruitment and treatment of subjects is expected to be performed in 10 study centers.
Primary endpoint The primary endpoint is the composite of cardiovascular death, myocardial infarction, rehospitalization for angina or heart failure, and unplanned coronary angiography at 12 months.
Secondary endpoints Each of the components of the primary endpoint Seattle Angina Questionnaire SAQ-7 Physical limitation scale SAQ-7 angina stability scale SAQ-7 angina frequency scale SAQ-7 angina quality of life EQ-5D-5L Beck depression inventory
The SAQ-7 "angina frequency" domain has been shown to correlate to improvements in microvascular function in the WISE study. SAQ-7-7 has been also used in a number of studies, including the ISCHEMIA study.
Other patient questionnaires are also standardized tests for the assessment of quality of life, depression and symptom severity in coronary artery disease studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing coronary microvascular function assessment | – | Device: Assessment of microvascular function with intracoronary hemodilution |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angina without apparent obstructive coronary artery disease (no coronary stenosis >75% at angiography) undergoing clinically-indicated assessment of coronary microvascular function.
Key inclusion criteria (10 listed)
- Age ≥ 18 and <85 years.
- Chronic coronary syndrome (including patients with anginal equivalents)
- Angina CCS class II-IV
- Evidence of reversible ischemia on non-invasive testing
- Availability of the following measurements:
Key exclusion criteria (9 listed)
- Pregnancy and or lactation.
- Medical or psychological conditions that would jeopardize an adequate and orderly participation.
- Left ventricular ejection fraction lower than 30%
- Previous coronary artery bypass surgery (CABG) to all major branches in the LAD and left circumflex (LCX) territory, such that IMR cannot be measured
- Decompensated congestive heart failure (CHF)
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 |
|---|---|---|
| Assessment of microvascular function with intracoronary hemodilutionThe pressure/temperature wire allows assessing coronary flow reserve, intracoronary pressure, and coronary flow to calculate multiple parameters of coronary macro- and microvascular function. | Device | Patients undergoing coronary microvascular function assessment |
Primary outcome
Prognostic impact of resting resistances
Time frame: 12 months
The impact of resting resistances (expressed as Mean Transit Time, i.e. time for a saline bolus to reach the wire thermistor times distal pressure) on the incidence of patient-oriented outcomes (composite of cardiovascular death, myocardial infarction, rehospitalization for angina or heart failure and unplanned coronary angiography) at 12 months
6 secondary outcomes
Correlation between SAQ measures and IMR
Time frame: 6 months, 1 year and yearly to 5 years.
Correlation between depression and IMR
Time frame: 6 months, 1 year and yearly to 5 years.
Correlation between physical ability and IMR
Time frame: 6 months, 1 year and yearly to 5 years.
Distribution of mean transit time (Tmn)
Time frame: At inclusion
Distribution of index of microvascular resistances (IMR)
Time frame: At inclusion
Distribution of aortic and distal pressure
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
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 Disease, run by Johannes Gutenberg University Mainz 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 31 Mar 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Gori, Dott med, PhD (+496131 17 ext. 2829, tommaso.gori@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic impact of resting resistances (time frame: 12 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 31 Mar 2022.