MicrocirculationCCMDNCT06368635
The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study
An observational study of Microcirculation and Coronary Artery Disease, run by Weijing Wang at 1 site in China.
Trial summary
Ischaemic heart disease (IHD) and degenerative brain disease are two major sources of death and disability affecting all countries. While the consequences of obstructive disease in major vessels supplying blood to both organs have been widely documented, less attention has been paid to disease processes affecting the… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Microcirculation, Coronary Artery Disease, Cerebrovascular Circulation
- What is being tested?
- Coronary angiography
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Mar 2025
- 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 45 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with stable coronary lesions (stable coronary disease or lesions in nonculprit vessels \>48 hours after acute coronary syndrome) with clinical indication to coronary angiography and intermediate coronary lesions (visual estimation) suitable for FFR-guided revascularization.
Who may be able to join
- Informed Consent available.
- Age 45-80 years.
- Stable coronary lesions.
- target vessel with intermediate coronary lesion (40-80% diameter stenosis and FFR ≥0.8； or severe stenosis（>80%）after successful PCI and FFR ≥0.8
Who cannot join
- Previous myocardial infarction in the territory of distribution of the target vessel.
- Aortic valve stenosis (moderate or severe) .
- Severe left ventricle hypertrophy.
- Left ventricle moderate systolic dysfunction (EF < 35%).
- Contraindications to adenosine.
- Previous CABG (Coronary artery bypass grafting) with permeable grafts.
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- Contraindication to stent implantation.
- Severe anemia.
- Unilateral or bilateral carotid artery stenosis (> 50%).
- Unilateral or bilateral middle cerebral arteries (>50%).
- Previous cognitive decline, baseline MoCA less than 16 points.
- Coagulopathies or chronic anticoagulation.
- Platelets < 75000 o > 700.000.
- Previous stroke or intracranial hemorrhage.
- Contraindication to MRI.
- Chronic Renal Failure contraindicating gadolinium infusion during MRI: estimated glomerular filtration rate (eGFR) < 60 ml/min), hemodialysis, previous renal transplantation.
- Pacemaker/ Implantable Cardioverter Device with contraindication to MRI.
- Planned cardiac surgery.
- Life expectancy < 1 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100000
Weijing Wang, PhD, +8601088326200, wangweijing99@163.com
About this study
Official title: The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study（CCMD）
Ischaemic heart disease (IHD) and degenerative brain disease are two major sources of death and disability affecting all countries. While the consequences of obstructive disease in major vessels supplying blood to both organs have been widely documented, less attention has been paid to disease processes affecting the microcirculation that may affect cardiac and cerebral function. Yet, over the last decade significant progress has been made in understanding the substrate of microvascular disease in both organs. In the heart, arteriolar thickening and capillary rarefaction that reduce the conductance of the microvasculature and its ability to vasodilate in response to increased myocardial oxygen demands constitute the leading cause of coronary microvascular dysfunction (CMD). In the brain, concentric hyaline thickening of deep penetrating small arteries (arteriolosclerosis) with associated fibrosis of the vessel wall constitutes the most frequent substrate for cerebral small vessel disease (CSVD). Of note, both CMD and CSVD share common risk factors, such as age, hypertension, and diabetes.3 These factors might have a common effect on the microvascular domain of cardiac and cerebral vascular beds.
Although a potential link between both conditions has been hypothesized based on the similarities between pathological changes and risk factors, advance in knowledge exploring this has been hampered by lacking objective evidence of CMD and pathological brain changes indicative of CSVD in prior research studies. Thus, the relationship between CMD and CSVD is unknown.
The main objective of this study was to analyse the relationship between cerebrovascular disease and CMD in patients with atherosclerotic coronary artery disease (CAD).
- Being tested
- Coronary angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiographyDiagnostic test
target vessel with intermediate coronary lesion (40-80% diameter stenosis and FFR(fractional flow reserve) ≥0.8； or severe stenosis（>80%）after successful PCI(percutaneous coronary intervention) and FFR ≥0.8
| Study group | Role | What they receive |
|---|---|---|
| CCMD | The correlation between coronary microcirculation disease and cerebral microcirculation Receives: Diagnostic Test: Coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
Measured: 1 month
MACE
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
Measured: 12 month
Secondary outcomes (2)
Cerebral microcirculation
Determined by Cerebral MRI and Montreal Cognitive Assessment (MoCA) assessment. Montreal Cognitive Assessment (MoCA) The maximum score is 30 points, and the minimum score is 0 points. The lower the score, the more severe the cognitive impairment. A score of 26 or above is normal; 22-25 points: Mild cognitive decline; 16-21 points: Moderate cognitive decline; Below 16 points: Severe cognitive decline.
Measured: baseline
Cerebral microcirculation
Determined by Cerebral MRI and Montreal Cognitive Assessment (MoCA) assessment. Montreal Cognitive Assessment (MoCA) The maximum score is 30 points, and the minimum score is 0 points. The lower the score, the more severe the cognitive impairment. A score of 26 or above is normal; 22-25 points: Mild cognitive decline; 16-21 points: Moderate cognitive decline; Below 16 points: Severe cognitive decline.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weijing Wang
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor-investigator, Weijing Wang, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368635
- Sponsor's protocol ID
- 2022-GSP-QN-8
- Acronym
- CCMD
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study（CCMD）
- ClinicalTrials.gov ID
- NCT06368635
- Acronym / sponsor ID
- CCMD / 2022-GSP-QN-8
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Weijing WangOther government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 16 Apr 2024 (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.
Ischaemic heart disease (IHD) and degenerative brain disease are two major sources of death and disability affecting all countries. While the consequences of obstructive disease in major vessels supplying blood to both organs have been widely documented, less attention has been paid to disease processes affecting the microcirculation that may affect cardiac and cerebral function. Yet, over the last decade significant progress has been made in understanding the substrate of microvascular disease in both organs. In the heart, arteriolar thickening and capillary rarefaction that reduce the conductance of the microvasculature and its ability to vasodilate in response to increased myocardial oxygen demands constitute the leading cause of coronary microvascular dysfunction (CMD). In the brain, concentric hyaline thickening of deep penetrating small arteries (arteriolosclerosis) with associated fibrosis of the vessel wall constitutes the most frequent substrate for cerebral small vessel disease (CSVD). Of note, both CMD and CSVD share common risk factors, such as age, hypertension, and diabetes.3 These factors might have a common effect on the microvascular domain of cardiac and cerebral vascular beds.
Although a potential link between both conditions has been hypothesized based on the similarities between pathological changes and risk factors, advance in knowledge exploring this has been hampered by lacking objective evidence of CMD and pathological brain changes indicative of CSVD in prior research studies. Thus, the relationship between CMD and CSVD is unknown.
The main objective of this study was to analyse the relationship between cerebrovascular disease and CMD in patients with atherosclerotic coronary artery disease (CAD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCMD | – | Diagnostic Test: Coronary angiographyThe correlation between coronary microcirculation disease and cerebral microcirculation |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with stable coronary lesions (stable coronary disease or lesions in nonculprit vessels \>48 hours after acute coronary syndrome) with clinical indication to coronary angiography and intermediate coronary lesions (visual estimation) suitable for FFR-guided revascularization.
Key inclusion criteria (4 listed)
- Informed Consent available.
- Age 45-80 years.
- Stable coronary lesions.
- target vessel with intermediate coronary lesion (40-80% diameter stenosis and FFR ≥0.8； or severe stenosis（>80%）after successful PCI and FFR ≥0.8
Key exclusion criteria (19 listed)
- Previous myocardial infarction in the territory of distribution of the target vessel.
- Aortic valve stenosis (moderate or severe) .
- Severe left ventricle hypertrophy.
- Left ventricle moderate systolic dysfunction (EF < 35%).
- Contraindications to adenosine.
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 |
|---|---|---|
| Coronary angiographytarget vessel with intermediate coronary lesion (40-80% diameter stenosis and FFR(fractional flow reserve) ≥0.8； or severe stenosis（>80%）after successful PCI(percutaneous coronary intervention) and FFR ≥0.8 | Diagnostic test | CCMD |
Primary outcome
MACE
Time frame: 1 month
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
MACE
Time frame: 12 month
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
2 secondary outcomes
Cerebral microcirculation
Time frame: baseline
Cerebral microcirculation
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No. The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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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 Microcirculation and Coronary Artery Disease, run by Weijing Wang at 1 site in China.
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 4 inclusion and 19 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 18 Apr 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 China. 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 Weijing Wang Weijing Wang PhD, PhD (+86-010-88396282, wangweijing99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 1 month). The study lists 2 primary outcomes in all. 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 18 Apr 2024.