Acute Myocardial InfarctionPhase 4EDUCATE-AMINCT00712894
Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction
A Phase 4 study testing Diltiazem, Verapamil and Nitroglycerin in people with Acute Myocardial Infarction and Percutaneous Coronary Intervention, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction, Percutaneous Coronary Intervention
- What is being tested?
- Diltiazem, Verapamil and Nitroglycerin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Dec 2006to Aug 2009
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute myocardial infarction
- Vessel TIMI flow < grade Ⅲ post-PCI
Who cannot join
- Heart failure of New York Heart Association (NYHA) class Ⅲ to class Ⅳ
- Sick sinus syndrome
- Atrioventricular block (grade Ⅱ and above)
- SBP ≤ 90mmHg or cardiogenic shock
- Heart Rate ≤60 bpm
- Pregnancy
- Renal or hepatic failure
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Reversal of No-reflow/Slow-flow During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction--a Prospective Randomized Study Comparing Intracoronary Infusion of Diltiazem, Verapamil and Nitroglycerin
The purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction.
Read the detailed description
No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a poor clinical outcome. The present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage. This prospective randomized study aimed to confirm favorable effects of diltiazem on no-reflow/slow-flow during direct PCI for AMI compared with verapamil and nitroglycerin.
- Being tested
- Diltiazem, Verapamil, Nitroglycerin
- Keywords
- Acute myocardial infarction, Percutaneous coronary intervention, No-reflow phenomenon, Vasodilator agents
- Medical subject headings
- No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiltiazemDrug
Intracoronary Infusion 400-2000ug
VerapamilDrug
Intracoronary Infusion 200-1000ug
NitroglycerinDrug
Intracoronary Infusion 200-1000ug
| Study group | Role | What they receive |
|---|---|---|
| D | Experimental | If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of diltiazem via an infusion microcatheter distal to the angioplasty site was performed. Receives: Drug: Diltiazem |
| V | Active comparator | If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of verapamil via an infusion microcatheter distal to the angioplasty site was performed. Receives: Drug: Verapamil |
| N | Active comparator | If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of nitroglycerin via an infusion microcatheter distal to the angioplasty site was performed. Receives: Drug: Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel flow using TIMI flow grade and TIMI frame count
Measured: post-PCI
Secondary outcomes (5)
major adverse cardiovascular events (MACE)
Measured: within the first 30 days after PCI
Left ventricular ejection fraction (LVEF) through echocardiography
Measured: at 1 and 30 days post-PCI
NT-proBNP levels
Measured: at 1 and 30 days post-PCI
incidence of complete ST-segment resolution
Measured: 3 hours after PCI
peak troponin T level
Measured: 24 hours after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startDec 2006
- Primary completionApr 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ge Junbo, Fudan University
- Investigators
- Junbo Ge, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712894
- Sponsor's protocol ID
- Zhongshan 2006-70
- Acronym
- EDUCATE-AMI
- Status last verified
- Sep 2012
- First submitted
- 8 Jul 2008
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang D, Qian J, Ge L, Jin X, Jin H, Ma J, Liu Z, Zhang F, Dong L, Wang X, Yao K, Ge J. REstoration of COronary flow in patients with no-reflow after primary coronary interVEntion of acute myocaRdial infarction (RECOVER). Am Heart J. 2012 Sep;164(3):394-401. doi: 10.1016/j.ahj.2012.06.015.
PubMed 22980307
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of No-reflow/Slow-flow During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction--a Prospective Randomized Study Comparing Intracoronary Infusion of Diltiazem, Verapamil and Nitroglycerin
- ClinicalTrials.gov ID
- NCT00712894
- Acronym / sponsor ID
- EDUCATE-AMI / Zhongshan 2006-70
- Keywords
- Acute myocardial infarction, Percutaneous coronary intervention, No-reflow phenomenon, Vasodilator agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Jul 2008 (estimated)
- 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 purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction.
Detailed description
No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a poor clinical outcome. The present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage. This prospective randomized study aimed to confirm favorable effects of diltiazem on no-reflow/slow-flow during direct PCI for AMI compared with verapamil and nitroglycerin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D | Experimental | Drug: DiltiazemIf no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of diltiazem via an infusion microcatheter distal to the angioplasty site was performed. |
| V | Active comparator | Drug: VerapamilIf no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of verapamil via an infusion microcatheter distal to the angioplasty site was performed. |
| N | Active comparator | Drug: NitroglycerinIf no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of nitroglycerin via an infusion microcatheter distal to the angioplasty site was performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute myocardial infarction
- Vessel TIMI flow < grade Ⅲ post-PCI
Key exclusion criteria (7 listed)
- Heart failure of New York Heart Association (NYHA) class Ⅲ to class Ⅳ
- Sick sinus syndrome
- Atrioventricular block (grade Ⅱ and above)
- SBP ≤ 90mmHg or cardiogenic shock
- Heart Rate ≤60 bpm
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 |
|---|---|---|
| DiltiazemIntracoronary Infusion 400-2000ug | Drug | D |
| VerapamilIntracoronary Infusion 200-1000ug | Drug | V |
| NitroglycerinIntracoronary Infusion 200-1000ug | Drug | N |
Primary outcome
Vessel flow using TIMI flow grade and TIMI frame count
Time frame: post-PCI
5 secondary outcomes
major adverse cardiovascular events (MACE)
Time frame: within the first 30 days after PCI
Left ventricular ejection fraction (LVEF) through echocardiography
Time frame: at 1 and 30 days post-PCI
NT-proBNP levels
Time frame: at 1 and 30 days post-PCI
incidence of complete ST-segment resolution
Time frame: 3 hours after PCI
peak troponin T level
Time frame: 24 hours after PCI
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 24 Sep 2012.
- Results publication: PubMed 22980307Huang D, Qian J, Ge L, Jin X, Jin H, Ma J, Liu Z, Zhang F, Dong L, Wang X, Yao K, Ge J. REstoration of COronary flow in patients with no-reflow after primary coronary interVEntion of acute myocaRdial infarction (RECOVER). Am Heart J. 2012 Sep;164(3):394-401. doi: 10.1016/j.ahj.2012.06.015.
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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.
Junbo Ge, M.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diltiazem, Verapamil and Nitroglycerin in people with Acute Myocardial Infarction and Percutaneous Coronary Intervention, run by Fudan 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 7 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 24 Sep 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vessel flow using TIMI flow grade and TIMI frame count (time frame: post-PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712894, which also lists 1 linked publication.
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 24 Sep 2012; AzTrials last refreshed its copy on 26 Oct 2026.