Coronary Microvascular DysfunctionNCT04959357
The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease
An observational study of Coronary Microvascular Dysfunction and Obstructive Coronary Heart Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
The study was designed to evaluate the left ventricular longitudinal strain and strain rate assessed by 2D-STI in patients with coronary microvascular dysfunction (CMD) or obstructive coronary artery disease (CAD) , to investigate the effect of different types of ischemic heart disease on the LV systolic function, and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Microvascular Dysfunction, Obstructive Coronary Heart Disease
- What is being tested?
- Two dimensional speckle tracking imaging
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2018to 30 Dec 2018
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 242 patients were enrolled, including 102 males (42.1%) and 140 females (57.9%). Their ages ranged from 44 to 81 years, with an average age of (62.6 + 8.3) years.
Who may be able to join
- age from 18-85 years
Who cannot join
- patients with history of myocardial infarction or abnormal wall motion suggested by conventional echocardiography
- patients with acute heart failure, chronic heart failure or LVEF values less than 50%
- patients with congenital heart disease, severe valvular disease, severe bradycardia, high atrioventricular block and atrial fibrillation
- patients who did not store ultrasound images or whose ultrasound images were unclear
- patients who had incomplete clinical data
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides
Beijing, Beijing Municipality, 100191
About this study
Official title: The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease by Two-dimensional Speckle-tracking Echocardiography
The study was designed to evaluate the left ventricular longitudinal strain and strain rate assessed by 2D-STI in patients with coronary microvascular dysfunction (CMD) or obstructive coronary artery disease (CAD) , to investigate the effect of different types of ischemic heart disease on the LV systolic function, and to explore the value of LS on the diagnosis of coronary microvascular dysfunction.
Read the detailed description
A total of 175 patients with chest pain, without wall motion abnormality and without significant coronary artery stenosis (<50%) assessed by coronary angiography or coronary computed tomography were enrolled from July 2011 to December 2017. Coronary flow reserve (CFR) of these patients were detected by transthoracic Doppler echocardiography. The patients were divided into coronary microvascular dysfunction group ( CFR≤2.5, n=67) and control group (CFR>2.5, n=108). At the same time, 67 age-matched patients with any major coronary arteries stenosis≥50% and without wall motion abnormality were involved into the obstructive coronary artery disease group. Parameters of global longitudinal strain (LS) and strain rate, subendocardial LS and subepicardial LS were quantified by 2D-STI, the differences of these parameters among three groups were analyzed，correlation analysis、univariate and multivariate analysis and receiver operating characteristic curve were used.
- Being tested
- Two dimensional speckle tracking imaging
- Keywords
- two-dimensional speckle tracking imaging, strain, coronary microvascular dysfunction
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two dimensional speckle tracking imagingDiagnostic test
lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging
| Study group | Role | What they receive |
|---|---|---|
| coronary microvascular dysfunction group | Not described Receives: Diagnostic Test: Two dimensional speckle tracking imaging | |
| obstructive coronary artery disease | Not described Receives: Diagnostic Test: Two dimensional speckle tracking imaging | |
| control group | Not described Receives: Diagnostic Test: Two dimensional speckle tracking imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
global longitudinal strain
global longitudinal strain of CMD group and obstructive CAD group
Measured: 15/3/2018-30/12/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start15 Mar 2018
- Primary completion30 Oct 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DysfunctionStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Zhaoping, professor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959357
- Sponsor's protocol ID
- 048-01
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease by Two-dimensional Speckle-tracking Echocardiography
- ClinicalTrials.gov ID
- NCT04959357
- Acronym / sponsor ID
- 048-01
- Keywords
- two-dimensional speckle tracking imaging, strain, coronary microvascular dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 13 Jul 2021 (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 study was designed to evaluate the left ventricular longitudinal strain and strain rate assessed by 2D-STI in patients with coronary microvascular dysfunction (CMD) or obstructive coronary artery disease (CAD) , to investigate the effect of different types of ischemic heart disease on the LV systolic function, and to explore the value of LS on the diagnosis of coronary microvascular dysfunction.
Detailed description
A total of 175 patients with chest pain, without wall motion abnormality and without significant coronary artery stenosis (<50%) assessed by coronary angiography or coronary computed tomography were enrolled from July 2011 to December 2017. Coronary flow reserve (CFR) of these patients were detected by transthoracic Doppler echocardiography. The patients were divided into coronary microvascular dysfunction group ( CFR≤2.5, n=67) and control group (CFR>2.5, n=108). At the same time, 67 age-matched patients with any major coronary arteries stenosis≥50% and without wall motion abnormality were involved into the obstructive coronary artery disease group. Parameters of global longitudinal strain (LS) and strain rate, subendocardial LS and subepicardial LS were quantified by 2D-STI, the differences of these parameters among three groups were analyzed，correlation analysis、univariate and multivariate analysis and receiver operating characteristic curve were used.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| coronary microvascular dysfunction group | – | Diagnostic Test: Two dimensional speckle tracking imaging |
| obstructive coronary artery disease | – | Diagnostic Test: Two dimensional speckle tracking imaging |
| control group | – | Diagnostic Test: Two dimensional speckle tracking imaging |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 242 patients were enrolled, including 102 males (42.1%) and 140 females (57.9%). Their ages ranged from 44 to 81 years, with an average age of (62.6 + 8.3) years.
Key inclusion criteria (1 listed)
- age from 18-85 years
Key exclusion criteria (5 listed)
- patients with history of myocardial infarction or abnormal wall motion suggested by conventional echocardiography
- patients with acute heart failure, chronic heart failure or LVEF values less than 50%
- patients with congenital heart disease, severe valvular disease, severe bradycardia, high atrioventricular block and atrial fibrillation
- patients who did not store ultrasound images or whose ultrasound images were unclear
- patients who had incomplete clinical data
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 |
|---|---|---|
| Two dimensional speckle tracking imaginglobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging | Diagnostic test | control group, coronary microvascular dysfunction group, obstructive coronary artery disease |
Primary outcome
global longitudinal strain
Time frame: 15/3/2018-30/12/2018
global longitudinal strain of CMD group and obstructive CAD group
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 13 Jul 2021.
- 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. This study is not recruiting at the moment.
Li Zhaoping, professor study chair
Peking University Third Hospital
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 Coronary Microvascular Dysfunction and Obstructive Coronary Heart Disease, run by Peking University Third Hospital 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 1 inclusion and 5 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 13 Jul 2021. 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?
global longitudinal strain (time frame: 15/3/2018-30/12/2018). 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 Jul 2021.