Myocardial InfarctionPhase 4NCT07268586
Intravenous Atropine in Reducing Reperfusion Arrhythmias, Conduction Abnormalities and Hypotension in Inferior ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
A Phase 4 study testing Intravenous atropine immediately before wire crossing during primary percutaneous coronary intervention in people with Myocardial Infarction, run by Ain Shams University at 1 site in Egypt.
Trial summary
People with acute inferior wall myocardial infarction will be given an intravenous drug called atropine that increases the heart rate to check if it prevents heart rhythm disturbances during performing coronary intervention Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Intravenous atropine immediately before wire crossing during primary percutaneous coronary intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 28 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute inferior ST elevation myocardial infarction
Who cannot join
- Execution of rescur percutaneous coronary intervention after thrombolysis
- Mechanical complications or no reflow or spontaneous reperfusion.
- Prior implantation of permanent or temporary pacemakers
- History of bradycardia, hypotension or ventricular tachycardia with a definitive cause (unrelated to the disease under study)
- Prior coronary artery bypass graft surgery
- Atropine contraindications Unwillingness to participate in the
Trial locations and contacts
1 site in 1 country.
About this study
People with acute inferior wall myocardial infarction will be given an intravenous drug called atropine that increases the heart rate to check if it prevents heart rhythm disturbances during performing coronary intervention
- Conditions
- Myocardial Infarction
- Being tested
- Intravenous atropine immediately before wire crossing during primary percutaneous coronary intervention, Intravenous normal saline as placebo immediately before wire crossing during primary percutaneous coronary intervention
- Keywords
- Atropine, Inferior ST elevation 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.
Intravenous atropine immediately before wire crossing during primary percutaneous coronary interventionDrug
Intravenous atropine 1 mg immediately before wire crossing during primary percutaneous coronary intervention
Intravenous normal saline as placebo immediately before wire crossing during primary percutaneous coronary interventionDrug
Intravenous normal saline as placebo immediately before wire crossing during primary percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Atropine arm | Active comparator | This group will receive intravenous atropine 1 mg immediately before wire crossing Receives: Drug: Intravenous atropine immediately before wire crossing during primary percutaneous coronary intervention |
| Placebo arm | Placebo comparator | This group will receive intravenous normal saline immediately before wire crossing Receives: Drug: Intravenous normal saline as placebo immediately before wire crossing during primary percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conduction abnormalities
Occurrence of conduction abnormalities
Measured: Periprocedurally
Reperfusion arrhythmias
Occurrence of reperfusion arrhythmias
Measured: Periprocedurally
Secondary outcomes (1)
Major adverse cardiac events
Inhospital major adverse cardiac events including all-cause mortality, cardiovascular mortality, stroke and myocardial infarction
Measured: Periprocedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Aug 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
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 Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268586
- Sponsor's protocol ID
- FMASU R49/2025
- Status last verified
- Oct 2025
- First submitted
- 1 Nov 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rashed MI, Bastawy IM, Mohamed AL, Elewa MG. Intravenous Atropine in Reducing Reperfusion Arrhythmias, Conduction Abnormalities, and Hypotension in Inferior ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. J Saudi Heart Assoc. 2026 May 25;38(2):10. doi: 10.37616/2212-5043.1505. eCollection 2026.
PubMed 42305382
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Atropine in Reducing Reperfusion Arrhythmias, Conduction Abnormalities and Hypotension in Inferior ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07268586
- Acronym / sponsor ID
- FMASU R49/2025
- Conditions
- Myocardial Infarction
- Keywords
- Atropine, Inferior ST elevation myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 8 Dec 2025 (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.
People with acute inferior wall myocardial infarction will be given an intravenous drug called atropine that increases the heart rate to check if it prevents heart rhythm disturbances during performing coronary intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine arm | Active comparator | Drug: Intravenous atropine immediately before wire crossing during primary percutaneous coronary interventionThis group will receive intravenous atropine 1 mg immediately before wire crossing |
| Placebo arm | Placebo comparator | Drug: Intravenous normal saline as placebo immediately before wire crossing during primary percutaneous coronary interventionThis group will receive intravenous normal saline immediately before wire crossing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute inferior ST elevation myocardial infarction
Key exclusion criteria (6 listed)
- Execution of rescur percutaneous coronary intervention after thrombolysis
- Mechanical complications or no reflow or spontaneous reperfusion.
- Prior implantation of permanent or temporary pacemakers
- History of bradycardia, hypotension or ventricular tachycardia with a definitive cause (unrelated to the disease under study)
- Prior coronary artery bypass graft surgery
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 atropine immediately before wire crossing during primary percutaneous coronary interventionIntravenous atropine 1 mg immediately before wire crossing during primary percutaneous coronary intervention | Drug | Atropine arm |
| Intravenous normal saline as placebo immediately before wire crossing during primary percutaneous coronary interventionIntravenous normal saline as placebo immediately before wire crossing during primary percutaneous coronary intervention | Drug | Placebo arm |
Primary outcome
Conduction abnormalities
Time frame: Periprocedurally
Occurrence of conduction abnormalities
Reperfusion arrhythmias
Time frame: Periprocedurally
Occurrence of reperfusion arrhythmias
1 secondary outcome
Major adverse cardiac events
Time frame: Periprocedurally
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 10 Mar 2026.
- Derived from this study: PubMed 42305382Rashed MI, Bastawy IM, Mohamed AL, Elewa MG. Intravenous Atropine in Reducing Reperfusion Arrhythmias, Conduction Abnormalities, and Hypotension in Inferior ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. J Saudi Heart Assoc. 2026 May 25;38(2):10. doi: 10.37616/2212-5043.1505. eCollection 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intravenous atropine immediately before wire crossing during primary percutaneous coronary intervention in people with Myocardial Infarction, run by Ain Shams University at 1 site in Egypt.
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 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 10 Mar 2026. 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 Egypt. 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.
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?
Conduction abnormalities (time frame: Periprocedurally). 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?
On the ClinicalTrials.gov record for NCT07268586, 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 10 Mar 2026.