Coronary Microvascular DiseaseNCT04554004
A Non-invasive Index of Microciculatory Resistance
A study testing CCTA, CT-MPI, DSA, FFR in people with Coronary Microvascular Disease and Coronary Artery Disease, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Coronary artery microvascular disease (CMVD) lacks reliable and non-invasive quantitative diagnosis methods. Improving coronary microcirculation has become one of the main goals of coronary heart disease treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Microvascular Disease, Coronary Artery Disease
- What is being tested?
- CCTA, CT-MPI, DSA, FFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be older than 18 years
- Written informed consent available
- Subject is indicated for invasive coronary angiography
- Subject need to be taken within 30 days after enrolment
Who cannot join
- Previous PCI or CABG
- Subject is not eligible for measuring IMR
- Complicated complex congenital heart disease
- Artificial pacemaker or internal defibrillator leads implanted
- Implanted artificial heart valve
- Severe arrhythmia including complete AV block, ventricular arrhythmia
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- Impaired chronic renal function (serum creatinine>1.5ULN)
- Allergic to iodine
- Pregnancy
- Body mass index >35 kg/m2
- Left ventricle is markedly thickened
- Needs for emergency procedures
- Severe distortion of in the blood vessel
- Unstable haemodynamics including abrupt chest pain cardiogenic shock, unstable blood pressure (systolic < 90mmHg), severe congestive heart failure or pulmonary edema
- Life-threatening diseases (life expectancy < 2 months)
- Tako Tsubo syndrome (TTS)
- Others who are inappropriate subject judged by clinician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial for CT Myocardial Perfusion Based Non-invasive Index of Microciculatory Resistance
Coronary artery microvascular disease (CMVD) lacks reliable and non-invasive quantitative diagnosis methods. Improving coronary microcirculation has become one of the main goals of coronary heart disease treatment. In this study, by establishing the key influencing factors of myocardial microcirculation perfusion, an accurate three-dimensional reconstruction method of coronary artery was established, and a non-invasive coronary microcirculation resistance index (CT-IMR) calculation method based on computational fluid method mechanics was established. At the same time, a phase I single-center clinical verification and a multi-center clinical verification of the non-invasive coronary microcirculation function precision assessment system were carried out, and a non-invasive coronary microcirculation detection system and technology were established.
- Being tested
- CCTA, CT-MPI, DSA, FFR
- Medical subject headings
- Microvascular Angina, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTA, CT-MPI, DSA, FFRDiagnostic test
The patients who enrolled the study will undergo coronary CT angiography(CCTA), dynamic CT-MPI, invasive coronary angiography and invasive computation of fractional flow reserve (FFR)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | All consecutive patients undergoing outine CT angiography and dynamic CT-myocardial perfusion imaging(MPI) will be potentially eligible for inclusion in the trial. Assessment of coronary stenosis severity using invasive fractional flow reserve (FFR) and the status of myocardial microcirculation perfusion including coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed as part of invasive coronary angiography(CAG). Receives: Diagnostic Test: CCTA, CT-MPI, DSA, FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity
The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied.
Measured: up to 12 months
Secondary outcomes (1)
diagnostic
To study the diagnostic coincidence rate, positive predictive value and negative predictive value of CT-IMR in the diagnosis of microcirculation dysfunction.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start15 Dec 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinyu Huang, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554004
- Sponsor's protocol ID
- 2020C03018
- Status last verified
- Jun 2025
- First submitted
- 8 Sep 2020
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article after deidentification (text, table, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial for CT Myocardial Perfusion Based Non-invasive Index of Microciculatory Resistance
- ClinicalTrials.gov ID
- NCT04554004
- Acronym / sponsor ID
- 2020C03018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 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.
Coronary artery microvascular disease (CMVD) lacks reliable and non-invasive quantitative diagnosis methods. Improving coronary microcirculation has become one of the main goals of coronary heart disease treatment. In this study, by establishing the key influencing factors of myocardial microcirculation perfusion, an accurate three-dimensional reconstruction method of coronary artery was established, and a non-invasive coronary microcirculation resistance index (CT-IMR) calculation method based on computational fluid method mechanics was established. At the same time, a phase I single-center clinical verification and a multi-center clinical verification of the non-invasive coronary microcirculation function precision assessment system were carried out, and a non-invasive coronary microcirculation detection system and technology were established.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: CCTA, CT-MPI, DSA, FFRAll consecutive patients undergoing outine CT angiography and dynamic CT-myocardial perfusion imaging(MPI) will be potentially eligible for inclusion in the trial. Assessment of coronary stenosis severity using invasive fractional flow reserve (FFR) and the status of myocardial microcirculation perfusion including coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed as part of invasive coronary angiography(CAG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be older than 18 years
- Written informed consent available
- Subject is indicated for invasive coronary angiography
- Subject need to be taken within 30 days after enrolment
Key exclusion criteria (17 listed)
- Previous PCI or CABG
- Subject is not eligible for measuring IMR
- Complicated complex congenital heart disease
- Artificial pacemaker or internal defibrillator leads implanted
- Implanted artificial heart valve
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 |
|---|---|---|
| CCTA, CT-MPI, DSA, FFRThe patients who enrolled the study will undergo coronary CT angiography(CCTA), dynamic CT-MPI, invasive coronary angiography and invasive computation of fractional flow reserve (FFR) | Diagnostic test | Study group |
Primary outcome
sensitivity and specificity
Time frame: up to 12 months
The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied.
1 secondary outcome
diagnostic
Time frame: up to 12 months
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 4 Jun 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article after deidentification (text, table, figures, and appendices).
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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?
A study testing CCTA, CT-MPI, DSA, FFR in people with Coronary Microvascular Disease and Coronary Artery Disease, run by First People's Hospital of Hangzhou 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 17 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 4 Jun 2025. 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?
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?
sensitivity and specificity (time frame: up to 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 4 Jun 2025.