Anterior Myocardial InfarctionNCT03579914
Effect of Intravenous Metoprolol Combining RIC on Myocardial Protection in STEMI Patients
A study testing Metoprolol Injectable Product, Romote Ischemic Conditioning (RIC) and Metoprolol & RIC in people with Anterior Myocardial Infarction and Heart Failure, run by Harbin Medical University at 16 sites in China.
Trial summary
The main purpose of this study is to compare the myocardial protection effect of intravenous metoprolol combined with remote ischemic conditioning (RIC) and single treatment before reperfusion in Chinese patients with anterior STEMI. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Myocardial Infarction, Heart Failure
- What is being tested?
- Metoprolol Injectable Product, Romote Ischemic Conditioning (RIC) and Metoprolol & RIC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,206 participants
- Where
- 16 sitesChina
- Study dates
- 28 Nov 2017to 30 Aug 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 18 to 80 years;
- presenting within 12 h of symptoms onset, with anterior STEMI and planned for pPCI; anterior STEMI was defined as the occurrence of >20 min of chest pain and ST-segment elevation (>2 mm) in at least 2 contiguous precordial leads;
- sign informed consent;
Who cannot join
- systolic blood pressure < 110mmHg;
- cardiogenic shock or with heart failure symptoms, Killip III~IV;
- allergic history of metoprolol;
- history of asthma or the need for bronchodilators;
- PR interval > 240ms, II~III atrioventricular block；
- heart rate < 60 beats/min;
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- unable to consent;
- pregnancy and lactation women;
- life expectancy for diseases (i.e. cancer) < 1 year.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Peking Univerisity People'Hospital
Beijing, Beijing Municipality, 100044
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality
The Second Hospital of Jilin University
Changchun, Jilin, 130000
Third Military Medical University
Chongqing, Sichuan
the second affiliated hospital of Dalian medical university
Dalian, Liaoning
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001
Guangdong general hospital
Guangzhou, Guangdong
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Shenyang military district general hospital of the people's liberation army
Shenyang, Liaoning
Second hospital of hebei medical university
Shijiazhuang, Hebei
The General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Tianjin Chest Hospital
Tianjin, Tianjin Municipality
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
The first affiliated hospital of military medical university
Xi’an, Shanxi
The first affiliated hospital of Zhengzhou medical university
Zhengzhou, Henan
About this study
Official title: Combined Metoprolol and Remote Ischemic Conditioning in Cardioprotection of Anterior ST-segment Elevation Myocardial Infarction (METRICATION)
The main purpose of this study is to compare the myocardial protection effect of intravenous metoprolol combined with remote ischemic conditioning (RIC) and single treatment before reperfusion in Chinese patients with anterior STEMI. This study sought to find possible strategies to further improve myocardial protection in Chinese patients with anterior STEMI.
Read the detailed description
This study is a prospective, multi-center, randomized controlled study. It is planned to enroll 1200 patients with anterior STEMI. Immediately after the first medical contact, the patients who were determined by the investigator to meet the inclusion/exclusion criteria were randomized through the interactive web response system (IWRS) and received different pre-reperfusion treatments. The four groups were placebo group, metoprolol group, remote ischemic conditioning (RIC) group and metoprolol \& RIC group. Subsequently, the investigator conduct diagnosis and treatment according to the patient's specific conditions and check the serum level of myocardial damage markers (i.e. CK and CK-MB) at the time of admission, 12, 24, 36, 48, 60 hours, respectively. If the patient undergoes PCI treatment, additional detection of myocardial damage markers immediately after PCI is also required. All patients were followed for 1 year with an office visit or a telephone call at 1, 3, 6, 9 and 12 months to evaluate the health status and adverse clinical events of patients.
- Conditions
- Anterior Myocardial Infarction, Heart Failure
- Being tested
- intravenous Placebo, Metoprolol Injectable Product, Romote Ischemic Conditioning (RIC), Metoprolol & RIC
- Keywords
- Anterior Myocardial Infarction, Intravenous Metoprolol, RIC, Myocardial Protection
- Medical subject headings
- Anterior Wall Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous PlaceboDrug
Patients receive intravenous Placebo (saline) injection
Metoprolol Injectable ProductDrug
Patients receive intravenous Metoprolol injection
Romote Ischemic Conditioning (RIC)Device
Patients receive RIC treatment
Metoprolol & RICCombination product
Patients receive Metoprolol \& RIC treatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Patients receive intravenous placebo injection. Receives: Drug: intravenous Placebo |
| Intravenous metoprolol group | Experimental | Patients receive intravenous metoprolol injection. Receives: Drug: Metoprolol Injectable Product |
| RIC group | Experimental | Patients receive RIC treatment. Receives: Device: Romote Ischemic Conditioning (RIC) |
| Intravenous metoprolol and RIC group | Experimental | Patients receive intravenous metoprolol injection and RIC treatment. Receives: Combination Product: Metoprolol & RIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarct size
Estimating myocardial infarct size by area under CK, CK-MB curve
Measured: 60 hours
Secondary outcomes (4)
Major adverse cardiac and cerebrovascular events (MACCE)
Composition of death, heart failure, reinfarction, revascularization, malignant ventricular arrhythmias, stroke)
Measured: 1 year
Incidence of heart failure
Incidence of heart failure
Measured: 1 year
myocardial infarct size measured by MRI (optional)
myocardial infarct size measured by MRI (optional)
Measured: 7 days after AMI
Safety endpoint: incidence of severe bradycardia or hypotension
Severe bradycardia (heart rate <40bpm) or hypotension (systolic blood pressure <80mmHg)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start28 Nov 2017
- Primary completion31 Aug 2020
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Myocardial InfarctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579914
- Sponsor's protocol ID
- 2016YFC1301102
- Status last verified
- Oct 2021
- First submitted
- 17 May 2018
- Last updated
- 4 Nov 2021
- 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 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Metoprolol and Remote Ischemic Conditioning in Cardioprotection of Anterior ST-segment Elevation Myocardial Infarction (METRICATION)
- ClinicalTrials.gov ID
- NCT03579914
- Acronym / sponsor ID
- 2016YFC1301102
- Conditions
- Anterior Myocardial Infarction, Heart Failure
- Keywords
- Anterior Myocardial Infarction, Intravenous Metoprolol, RIC, Myocardial Protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,206 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 9 Jul 2018 (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 main purpose of this study is to compare the myocardial protection effect of intravenous metoprolol combined with remote ischemic conditioning (RIC) and single treatment before reperfusion in Chinese patients with anterior STEMI. This study sought to find possible strategies to further improve myocardial protection in Chinese patients with anterior STEMI.
Detailed description
This study is a prospective, multi-center, randomized controlled study. It is planned to enroll 1200 patients with anterior STEMI. Immediately after the first medical contact, the patients who were determined by the investigator to meet the inclusion/exclusion criteria were randomized through the interactive web response system (IWRS) and received different pre-reperfusion treatments. The four groups were placebo group, metoprolol group, remote ischemic conditioning (RIC) group and metoprolol \& RIC group. Subsequently, the investigator conduct diagnosis and treatment according to the patient's specific conditions and check the serum level of myocardial damage markers (i.e. CK and CK-MB) at the time of admission, 12, 24, 36, 48, 60 hours, respectively. If the patient undergoes PCI treatment, additional detection of myocardial damage markers immediately after PCI is also required. All patients were followed for 1 year with an office visit or a telephone call at 1, 3, 6, 9 and 12 months to evaluate the health status and adverse clinical events of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: intravenous PlaceboPatients receive intravenous placebo injection. |
| Intravenous metoprolol group | Experimental | Drug: Metoprolol Injectable ProductPatients receive intravenous metoprolol injection. |
| RIC group | Experimental | Device: Romote Ischemic Conditioning (RIC)Patients receive RIC treatment. |
| Intravenous metoprolol and RIC group | Experimental | Combination Product: Metoprolol & RICPatients receive intravenous metoprolol injection and RIC treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages 18 to 80 years;
- presenting within 12 h of symptoms onset, with anterior STEMI and planned for pPCI; anterior STEMI was defined as the occurrence of >20 min of chest pain and ST-segment elevation (>2 mm) in at least 2 contiguous precordial leads;
- sign informed consent;
Key exclusion criteria (9 listed)
- systolic blood pressure < 110mmHg;
- cardiogenic shock or with heart failure symptoms, Killip III~IV;
- allergic history of metoprolol;
- history of asthma or the need for bronchodilators;
- PR interval > 240ms, II~III atrioventricular block；
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 |
|---|---|---|
| intravenous PlaceboPatients receive intravenous Placebo (saline) injection | Drug | Placebo group |
| Metoprolol Injectable ProductPatients receive intravenous Metoprolol injection | Drug | Intravenous metoprolol group |
| Romote Ischemic Conditioning (RIC)Patients receive RIC treatment | Device | RIC group |
| Metoprolol & RICPatients receive Metoprolol \& RIC treatment | Combination product | Intravenous metoprolol and RIC group |
Primary outcome
Myocardial infarct size
Time frame: 60 hours
Estimating myocardial infarct size by area under CK, CK-MB curve
4 secondary outcomes
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 1 year
Incidence of heart failure
Time frame: 1 year
myocardial infarct size measured by MRI (optional)
Time frame: 7 days after AMI
Safety endpoint: incidence of severe bradycardia or hypotension
Time frame: 24 hours
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 Nov 2021.
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metoprolol Injectable Product, Romote Ischemic Conditioning (RIC) and Metoprolol & RIC in people with Anterior Myocardial Infarction and Heart Failure, run by Harbin Medical University at 16 sites 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 3 inclusion and 9 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 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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. Some participants in this study may receive a placebo. 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?
Myocardial infarct size (time frame: 60 hours). 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 Nov 2021.