Myocardial IschemiaNCT04224714
Clinical Study on the Correlation Between IMR（Index of Microcirculation Resistance） and FFR（Fractional Flow Reserve）
A study testing FFR in people with Myocardial Ischemia, run by The People's Hospital of Liaoning Province at 1 site in China.
Trial summary
To study the effect of myocardial microcirculation disturbance on coronary flow reserve fraction, compare the evaluation value of IMR, FFR and QCA on myocardial ischemia, and discuss the correlation among them. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- FFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 30 Sep 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:(1) Age: 18-75 years old, unlimited for men and women;
(2) Quantitative coronary angiography (QCA) showed that there was a critical lesion in the proximal or middle segment of the coronary artery (diameter stenosis rate was 50% - 70%), and the diameter of the artery was more than 2.5mm;
(3) Agree to participate in the study and sign informed consent
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Exclusion Criteria:(1) Patients with acute myocardial infarction within one month;
(2) Patients with congenital heart disease, severe valve disease, dilated cardiomyopathy, pulmonary heart disease and hypertrophic cardiomyopathy;
(3) With severe heart failure (NYHA cardiac function grade ≥ grade III or left ventricular ejection fraction < 35%);
(4) Patients with less than 1 year of stent implantation or with coronary artery bypass grafting;
(5) Patients with left main lesion, severe distorted calcification, open lesion, bifurcated lesion or complete occlusion;
(6) Patients with severe hepatorenal insufficiency;
(7) Contraindications to adenosine, aspirin and clopidogrel;
(8) Patients with advanced tumor or life expectancy less than 1 year;
(9) Patients with severe asthma or uncontrolled asthma;
(10) Women in pregnancy.
-
Trial locations and contacts
1 site in 1 country.
China1 site
The people's hospital of LiaoNing Province
Shenyang, Liaoning, 110016
About this study
To study the effect of myocardial microcirculation disturbance on coronary flow reserve fraction, compare the evaluation value of IMR, FFR and QCA on myocardial ischemia, and discuss the correlation among them.
Read the detailed description
In this study, 60 patients with critical lesions indicated by coronary angiography will be admitted. The investigators collected the basic clinical data (gender, age, body mass index, smoking history, hypertension, diabetes, hyperlipidemia), laboratory data (creatinine, cholesterol, triglycerides) and measured their FFR and IMR.
- Conditions
- Myocardial Ischemia
- Being tested
- FFR
- Keywords
- microcirculation resistance index (IMR), fractional flow reserve(FFR)
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFRCombination product
FFR measurement: Pressure guid wire(radianalyzer Xpress 12711) is produced in Switzerland. After the pressure of the aorta and the pressure guide wire is balanced, Send the pressure guide wire to the distal part of the lesion(more than 20 mm away from the lesion) . Adenosine is injected into the vein,then,record the FFR index 3 times and take the average value as the final measurement index.
| Study group | Role | What they receive |
|---|---|---|
| Coronary heart disease patient | Experimental | Quantitative coronary angiography (QCA) showed that there was a critical lesion in the proximal or middle segment of the coronary artery (diameter stenosis rate was 50% - 70%), and the diameter of the artery was more than 2.5mm Receives: Combination Product: FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMR
Resistance index of microcirculation
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Sep 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The People's Hospital of Liaoning Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhilin Miao, The People's Hospital of Liaoning Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224714
- Sponsor's protocol ID
- CTC-91616
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Correlation Between IMR（Index of Microcirculation Resistance） and FFR（Fractional Flow Reserve）
- ClinicalTrials.gov ID
- NCT04224714
- Acronym / sponsor ID
- CTC-91616
- Conditions
- Myocardial Ischemia
- Keywords
- microcirculation resistance index (IMR), fractional flow reserve(FFR)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The People's Hospital of Liaoning ProvinceUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 13 Jan 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.
To study the effect of myocardial microcirculation disturbance on coronary flow reserve fraction, compare the evaluation value of IMR, FFR and QCA on myocardial ischemia, and discuss the correlation among them.
Detailed description
In this study, 60 patients with critical lesions indicated by coronary angiography will be admitted. The investigators collected the basic clinical data (gender, age, body mass index, smoking history, hypertension, diabetes, hyperlipidemia), laboratory data (creatinine, cholesterol, triglycerides) and measured their FFR and IMR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary heart disease patient | Experimental | Combination Product: FFRQuantitative coronary angiography (QCA) showed that there was a critical lesion in the proximal or middle segment of the coronary artery (diameter stenosis rate was 50% - 70%), and the diameter of the artery was more than 2.5mm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| FFRFFR measurement: Pressure guid wire(radianalyzer Xpress 12711) is produced in Switzerland. After the pressure of the aorta and the pressure guide wire is balanced, Send the pressure guide wire to the distal part of the lesion(more than 20 mm away from the lesion) . Adenosine is injected into the vein,then,record the FFR index 3 times and take the average value as the final measurement index. | Combination product | Coronary heart disease patient |
Primary outcome
IMR
Time frame: one hour
Resistance index of microcirculation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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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 FFR in people with Myocardial Ischemia, run by The People's Hospital of Liaoning Province 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?
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 13 Jan 2020. 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?
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?
IMR (time frame: one hour). 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 13 Jan 2020.