Myocardial InfarctionPhase 4NCT00128791
Nitroprusside for Prevention of no-Reflow in Primary Angioplasty
A Phase 4 study testing Nitroprusside in people with Myocardial Infarction, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
In patients admitted with acute myocardial infarction, there is a total occlusion of a coronary artery. Even after emergency catheterization and angioplasty, in some patients, the resumed blood flow is suboptimal and impacts on heart function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Nitroprusside
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2003to Apr 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute ST elevation myocardial infarction (MI) patients planned for primary PCI
- Diagnostic angiography demonstrating a TIMI flow grade <3 in the coronary artery before the PCI
Who cannot join
- An admission electrocardiogram (ECG) showing complete left bundle branch block or a paced rhythm
- Systolic blood pressure < 90 mmHg
- A history of coronary bypass operation
- A known allergic reaction to nitroprusside
- Chronic hemodialysis
- Intravenous drug abuse
Show all 11Show fewer
- Pregnancy
- Rescue intervention after failed thrombolysis
- Contraindications to aspirin or clopidogrel
- Need for emergent coronary artery bypass surgery
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracoronary Nitroprusside for the Prevention of the No-Reflow Phenomenon Following Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction. A Randomized, Double Blind, Placebo-Controlled Clinical Trial
In patients admitted with acute myocardial infarction, there is a total occlusion of a coronary artery. Even after emergency catheterization and angioplasty, in some patients, the resumed blood flow is suboptimal and impacts on heart function. The study is aimed at examining whether nitroprusside, an anti-hypertension medication, given directly into the coronary artery, can improve the blood flow after the removal of the obstruction that caused the infarction.
Read the detailed description
Inadequate myocardial tissue perfusion despite successful relief of the culprit occlusion and restoration of epicardial coronary flow for ST-segment elevation acute myocardial infarction (STEMI) results in poor outcome. The investigators hypothesized that nitroprusside (NTP) injected intracoronary immediately before angioplasty might prevent no-reflow and improve vessel flow and myocardial perfusion.
- Conditions
- Myocardial Infarction
- Being tested
- Nitroprusside
- Keywords
- myocardial infarction, angioplasty, nitric oxide, prevention, acute myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroprussideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The coronary blood flow in the artery undergoing intervention following angioplasty as determined by the corrected Thrombolysis in Myocardial Infarction (TIMI) frame count (CTFC)
Proportion of patients with complete ST-segment resolution immediately after percutaneous coronary intervention (PCI)
Secondary outcomes (6)
The proportion of patients with TIMI grade 3 flow after the procedure
The proportion of patients with myocardial grade 3 blush after the procedure
The proportion of patients with complete ST-segment resolution at 24 hours post intervention
The proportion of patients requiring intra-aortic balloon counter-pulsation and its duration of use
Length of hospital stay
The combined rate of target vessel revascularization, myocardial infarction or death at 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startJan 2003
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Doron Zahger, MD, Principal investigator, Soroka UMC, Beer-sheva, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128791
- Sponsor's protocol ID
- sor323102ctil
- Status last verified
- May 2007
- First submitted
- 9 Aug 2005
- Last updated
- 25 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Nitroprusside for the Prevention of the No-Reflow Phenomenon Following Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction. A Randomized, Double Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00128791
- Acronym / sponsor ID
- sor323102ctil
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, angioplasty, nitric oxide, prevention, acute myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Apr 2005
- First posted
- 10 Aug 2005 (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.
In patients admitted with acute myocardial infarction, there is a total occlusion of a coronary artery. Even after emergency catheterization and angioplasty, in some patients, the resumed blood flow is suboptimal and impacts on heart function. The study is aimed at examining whether nitroprusside, an anti-hypertension medication, given directly into the coronary artery, can improve the blood flow after the removal of the obstruction that caused the infarction.
Detailed description
Inadequate myocardial tissue perfusion despite successful relief of the culprit occlusion and restoration of epicardial coronary flow for ST-segment elevation acute myocardial infarction (STEMI) results in poor outcome. The investigators hypothesized that nitroprusside (NTP) injected intracoronary immediately before angioplasty might prevent no-reflow and improve vessel flow and myocardial perfusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Acute ST elevation myocardial infarction (MI) patients planned for primary PCI
- Diagnostic angiography demonstrating a TIMI flow grade <3 in the coronary artery before the PCI
Key exclusion criteria (11 listed)
- An admission electrocardiogram (ECG) showing complete left bundle branch block or a paced rhythm
- Systolic blood pressure < 90 mmHg
- A history of coronary bypass operation
- A known allergic reaction to nitroprusside
- Chronic hemodialysis
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 |
|---|---|---|
| Nitroprusside | Drug | – |
Primary outcome
The coronary blood flow in the artery undergoing intervention following angioplasty as determined by the corrected Thrombolysis in Myocardial Infarction (TIMI) frame count (CTFC)
Proportion of patients with complete ST-segment resolution immediately after percutaneous coronary intervention (PCI)
6 secondary outcomes
The proportion of patients with TIMI grade 3 flow after the procedure
The proportion of patients with myocardial grade 3 blush after the procedure
The proportion of patients with complete ST-segment resolution at 24 hours post intervention
The proportion of patients requiring intra-aortic balloon counter-pulsation and its duration of use
Length of hospital stay
The combined rate of target vessel revascularization, myocardial infarction or death at 180 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2007.
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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.
Doron Zahger, MD principal investigator
Soroka UMC, Beer-sheva, Israel
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 Nitroprusside in people with Myocardial Infarction, run by Soroka University Medical Center at 1 site in Israel.
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 11 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: stopped early, as of the sponsor's last update on 25 May 2007. 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 Israel. 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 was stopped early. 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?
The coronary blood flow in the artery undergoing intervention following angioplasty as determined by the corrected Thrombolysis in Myocardial Infarction (TIMI) frame count (CTFC). 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 25 May 2007.