Cardiovascular DiseasesNCT04586582
ST-Segment Resolution as a Marker for Myocardial Scar in ST-Segment Elevation Myocardial Infarction
An observational study of Cardiovascular Diseases, run by Chongqing Medical University at 1 site in China.
Trial summary
Clinical studies found that poor ST-segment resolution (STR) in electrocardiogram (ECG) occurred in major adverse cardiovascular events (MACE), arrhythmia and heart failure was significantly higher . Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- ST-segment resolution <40.15%
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Apr 2019
- How long will I take part?
- 2 Weeks
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 42 patients.
Who may be able to join
- Single-branch coronary artery stenosis or occlusion
- Restoration of coronary perfusion to TIMI flow grade 3 after PCI
Who cannot join
- A prior history of the acute coronary syndrome
- Coronary revascularization
- Severe chronic kidney disease
- Intracardiac pacing leads or other implants precluding CMR-LGE
- Hemodynamic instability
- Known claustrophobia
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Chongqing medical university
Chongqing, Chongqing Municipality, 400016
About this study
Official title: The First Affiliated Hospital of Chongqing Medical University.
Clinical studies found that poor ST-segment resolution (STR) in electrocardiogram (ECG) occurred in major adverse cardiovascular events (MACE), arrhythmia and heart failure was significantly higher . In clinical work, in patients have poor ST-segment decline, the investigators found by CMR-LGE the corresponding myocardium become thinner and other signs of myocardial scar.
The investigators aimed to establish whether poor ST-segment resolution in ECG, as well as CMR-LGE, could detect the presence of myocardial scar in early STEMI patients. In order to provide convenient, cheap and widely used test method for patients who cannot tolerate CMR-LGE.
42 STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured on the baseline and 24 hours after PCI. The study population was divided into two groups by late gadolinium enhanced cardiac magnetic resonance (LGE- CMR), with transmural myocardial scar (>75%) or non-transmural myocardial scar (<75%).
- Conditions
- Cardiovascular Diseases
- Being tested
- ST-segment resolution <40.15%
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST-segment resolution <40.15%Diagnostic test
Forty-two STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured at emergency admission and at 24 h after PCI. Late gadolinium-enhanced cardiac magnetic resonance imaging (CMR-LGE) was performed 7 days after PCI to evaluate myocardial scars.
| Study group | Role | What they receive |
|---|---|---|
| ST-segment resolution <40.15% | ST-segment resolution <40.15% Receives: Diagnostic Test: ST-segment resolution <40.15% | |
| ST-segment resolution >40.15% | ST-segment resolution >40.15% Receives: Diagnostic Test: ST-segment resolution <40.15% |
What is being measured
The primary outcome is the main question the study is designed to answer.
ST-segment resolution<40.15%
CMR-LGE was performed to evaluate myocardial scars.
Measured: 1) Emergency admission: ST-segment elevations were measured. 2) 24 hours after PCI: ST-segment elevations were measured. 3) 7 days after PCI: CMR-LGE was performed.
ST-segment resolution>40.15%
CMR-LGE was performed to evaluate myocardial scars.
Measured: 1) Emergency admission: ST-segment elevations were measured. 2) 24 hours after PCI: ST-segment elevations were measured. 3) 7 days after PCI: CMR-LGE was performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jul 2017
- Primary completion30 Dec 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Dongying Zhang, phD., Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586582
- Sponsor's protocol ID
- 20180701
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Chongqing Medical University.
- ClinicalTrials.gov ID
- NCT04586582
- Acronym / sponsor ID
- 20180701
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 14 Oct 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.
Clinical studies found that poor ST-segment resolution (STR) in electrocardiogram (ECG) occurred in major adverse cardiovascular events (MACE), arrhythmia and heart failure was significantly higher . In clinical work, in patients have poor ST-segment decline, the investigators found by CMR-LGE the corresponding myocardium become thinner and other signs of myocardial scar.
The investigators aimed to establish whether poor ST-segment resolution in ECG, as well as CMR-LGE, could detect the presence of myocardial scar in early STEMI patients. In order to provide convenient, cheap and widely used test method for patients who cannot tolerate CMR-LGE.
42 STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured on the baseline and 24 hours after PCI. The study population was divided into two groups by late gadolinium enhanced cardiac magnetic resonance (LGE- CMR), with transmural myocardial scar (>75%) or non-transmural myocardial scar (<75%).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ST-segment resolution <40.15% | – | Diagnostic Test: ST-segment resolution <40.15%ST-segment resolution <40.15% |
| ST-segment resolution >40.15% | – | Diagnostic Test: ST-segment resolution <40.15%ST-segment resolution >40.15% |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 42 patients.
Key inclusion criteria (2 listed)
- Single-branch coronary artery stenosis or occlusion
- Restoration of coronary perfusion to TIMI flow grade 3 after PCI
Key exclusion criteria (6 listed)
- A prior history of the acute coronary syndrome
- Coronary revascularization
- Severe chronic kidney disease
- Intracardiac pacing leads or other implants precluding CMR-LGE
- Hemodynamic instability
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 |
|---|---|---|
| ST-segment resolution <40.15%Forty-two STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured at emergency admission and at 24 h after PCI. Late gadolinium-enhanced cardiac magnetic resonance imaging (CMR-LGE) was performed 7 days after PCI to evaluate myocardial scars. | Diagnostic test | ST-segment resolution <40.15%, ST-segment resolution >40.15% |
Primary outcome
ST-segment resolution<40.15%
Time frame: 1) Emergency admission: ST-segment elevations were measured. 2) 24 hours after PCI: ST-segment elevations were measured. 3) 7 days after PCI: CMR-LGE was performed.
CMR-LGE was performed to evaluate myocardial scars.
ST-segment resolution>40.15%
Time frame: 1) Emergency admission: ST-segment elevations were measured. 2) 24 hours after PCI: ST-segment elevations were measured. 3) 7 days after PCI: CMR-LGE was performed.
CMR-LGE was performed to evaluate myocardial scars.
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 14 Oct 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.
Dongying Zhang, phD. study director
First Affiliated Hospital of Chongqing Medical University
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 Cardiovascular Diseases, run by Chongqing Medical University 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 2 inclusion and 6 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 14 Oct 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?
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?
ST-segment resolution<40.15% (time frame: 1) Emergency admission: ST-segment elevations were measured. 2) 24 hours after PCI: ST-segment elevations were measured. 3) 7 days after PCI: CMR-LGE was performed.). 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 14 Oct 2020.