ST-Elevation Myocardial Infarction (STEMI)REFLOW AMINCT07898696
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
A study testing Adenosine and Standard Treatment only in people with ST-Elevation Myocardial Infarction (STEMI), run by Prof Muzaffar Ali Zahidi at 2 sites in Pakistan.
Trial summary
The REFLOW AMI Trial aims to determine whether prophylactic high-dose intracoronary adenosine reduces slow-flow or no-reflow (SNR) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Adenosine and Standard Treatment only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 2 sitesPakistan
- Study dates
- 14 Aug 2026to 14 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years and older of either gender
- Diagnosis of STEMI
- Undergoing primary PCI
Who cannot join
- Cardiogenic shock
- Severe hypotension (SBP <90 mmHg)
- Bradycardia with HR < 50 bpm without pacemaker
- Known hypersensitivity to adenosine
- Severe asthma or COPD with bronchospasm
- Pregnancy
Show all 9Show fewer
- Spontaneous coronary artery dissection (SCAD)
- Myocardial Infarction in non - obstructive coronaries (MINOCA)
- Lesions unable to be crossed with coronary wire
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Dow University of Health Sciences,Karachi
Karachi, Sindh
Mishal Zehra, MBBS;FCPS Cardiology, +923325576637, mishal.zehra@duhs.edu.pk
- Recruiting
Punjab institute of cardiology Lahore
Lahore, Punjab Province
Muzaffar Ali Zahidi, MBBS;FCPS MED,FCPS Cardiology, +923004358267, muzcardio@gmail.com
About this study
The REFLOW AMI Trial aims to determine whether prophylactic high-dose intracoronary adenosine reduces slow-flow or no-reflow (SNR) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
Slow-flow or no-reflow occurs when blood flow to the heart muscle remains reduced despite treatment of the blocked coronary artery. This complication can lead to greater heart muscle damage and worse clinical outcomes.
Read more
The study will evaluate a protocol involving 200 micrograms of intracoronary adenosine administered before each balloon or stent inflation during PPCI. Researchers will compare outcomes with standard PPCI care without prophylactic adenosine.
The main questions the study aims to answer are:
- Does prophylactic intracoronary adenosine reduce the incidence of slow-flow or no-reflow after PPCI?
- Does the protocol improve post-PCI coronary blood flow, assessed by TIMI flow grade and myocardial blush grade?
- What are the rates of major adverse cardiovascular events (MACE) during hospitalization and at 30 days?
- Does the protocol affect left ventricular ejection fraction (LVEF) at discharge and at 30 days?
- Does the protocol improve functional capacity at 30 days, assessed by the six-minute walk test?
- Is the prophylactic adenosine protocol safe?
Participants will undergo PPCI according to their assigned study group and will be assessed for angiographic outcomes, safety events, and clinical outcomes during hospitalization and follow-up, including at 30 days.
- Being tested
- Adenosine, Standard Treatment only
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Prophylactic administration of 200 micrograms of intracoronary adenosine immediately before each balloon inflation or stent deployment during primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI). Adenosine is administered rapidly, within less than 30 seconds before each inflation, according to the study protocol. No additional vasodilator agents are used as part of this prophylactic protocol. The intervention is intended to reduce coronary slow-flow/no-reflow and improve post-PCI myocardial perfusion.
Standard Treatment onlyOther
Placebo administered according to the study protocol alongside standard treatment for patients undergoing primary PCI for STEMI in control group
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Intracoronary adenosine (200µg) injected in less than thirty seconds just before each balloon or stent inflation. Receives: Drug: Adenosine |
| Control | Other | Participants receive standard treatment for ST-elevation myocardial infarction (STEMI), including primary percutaneous coronary intervention (PCI) and guideline-directed medical therapy, according to institutional protocols. No placebo is administered. Receives: Other: Standard Treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Slow-Flow or No-Reflow After PPCI
The proportion of participants with slow-flow or no-reflow on final post-PCI angiography, assessed using the Thrombolysis in Myocardial Infarction (TIMI) flow grade. Slow-flow/no-reflow is defined as final TIMI flow grade 0, 1, or 2 in the treated infarct-related artery, in the absence of a mechanical cause of impaired coronary flow.
Measured: During the primary PCI procedure, immediately after completion of PCI (Day 1)
Secondary outcomes (6)
Final TIMI Flow Grade
Thrombolysis in Myocardial Infarction (TIMI) Flow Grade ranges from 0 to 3. Grade 0 indicates no antegrade coronary flow, while Grade 3 indicates normal coronary flow. Higher scores indicate better coronary blood flow.
Measured: During the primary PCI procedure, immediately after completion of PCI (Day 1)
Myocardial Blush Grade After Primary PCI
Myocardial Blush Grade ranges from 0 to 3. Grade 0 indicates no myocardial blush, while Grade 3 indicates normal myocardial perfusion. Higher scores indicate better myocardial perfusion.
Measured: During the primary PCI procedure, immediately after completion of PCI (Day 1)
Incidence of Major Adverse Cardiovascular Events (MACE)
Proportion of participants experiencing a major adverse cardiovascular event, defined according to the study protocol as death, periprocedural myocardial infarction, or target-vessel revascularization (TVR). Events will be assessed during the index hospitalization and through 30 days after PCI.
Measured: At the time of Hospital Discharge (upto 10 Days) and at 30 days after PCI.
Safety of Prophylactic High-Dose Intracoronary Adenosine
Incidence of adverse events associated with the study intervention, including clinically significant bradycardia, atrioventricular block, hypotension, and other adverse events specified in the study protocol.
Measured: During the primary PCI procedure, immediately after completion of PCI (Day 1) & at time of Hospital Discharge (upto 10 Days) and at 30 days after PCI.
Left Ventricular Ejection Fraction at Discharge and 30 Days
Left ventricular ejection fraction (LVEF), expressed as a percentage, assessed using echocardiography at hospital discharge and at 30-day follow-up.
Measured: At the time of Hospital Discharge (upto 10 Days) and at 30 days after PCI.
Six-Minute Walk Distance at 30 Days
Functional exercise capacity assessed by the six-minute walk test. The distance walked in meters during six minutes will be recorded at the 30-day follow-up visit.
Measured: 30 days after PCI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start14 Aug 2026
- Primary completion14 Aug 2027 (estimated)
- Study completion14 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-Elevation Myocardial Infarction (STEMI)Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Muzaffar Ali Zahidi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Muzaffar Ali Zahidi, Punjab Institute of Cardology
- Investigators
- Muzaffar Ali Zahidi, MBBS,FCPS Med,FCPS Cardiology, Principal investigator, Punjab Institute of Cardiology Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898696
- Sponsor's protocol ID
- PIC-REFLOW-AMI-2026-001
- Acronym
- REFLOW AMI
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available, including demographic characteristics, baseline clinical features, procedural and angiographic data (including TIMI flow grade and myocardial blush grade), study intervention allocation, adverse events, major adverse cardiovascular events, left ventricular ejection fraction, and six-minute walk test results, where collected. Data will be shared without direct personal identifiers and subject to applicable ethical, institutional, and data-protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
- ClinicalTrials.gov ID
- NCT07898696
- Acronym / sponsor ID
- REFLOW AMI / PIC-REFLOW-AMI-2026-001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Prof Muzaffar Ali ZahidiUniversity, hospital or other
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- 14 Aug 2027 (estimated)
- Study completion
- 14 Aug 2027 (estimated)
- First posted
- 27 Oct 2026 (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 REFLOW AMI Trial aims to determine whether prophylactic high-dose intracoronary adenosine reduces slow-flow or no-reflow (SNR) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
Slow-flow or no-reflow occurs when blood flow to the heart muscle remains reduced despite treatment of the blocked coronary artery. This complication can lead to greater heart muscle damage and worse clinical outcomes.
The study will evaluate a protocol involving 200 micrograms of intracoronary adenosine administered before each balloon or stent inflation during PPCI. Researchers will compare outcomes with standard PPCI care without prophylactic adenosine.
The main questions the study aims to answer are:
- Does prophylactic intracoronary adenosine reduce the incidence of slow-flow or no-reflow after PPCI?
- Does the protocol improve post-PCI coronary blood flow, assessed by TIMI flow grade and myocardial blush grade?
- What are the rates of major adverse cardiovascular events (MACE) during hospitalization and at 30 days?
- Does the protocol affect left ventricular ejection fraction (LVEF) at discharge and at 30 days?
- Does the protocol improve functional capacity at 30 days, assessed by the six-minute walk test?
- Is the prophylactic adenosine protocol safe?
Participants will undergo PPCI according to their assigned study group and will be assessed for angiographic outcomes, safety events, and clinical outcomes during hospitalization and follow-up, including at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: AdenosineIntracoronary adenosine (200µg) injected in less than thirty seconds just before each balloon or stent inflation. |
| Control | Other | Other: Standard Treatment onlyParticipants receive standard treatment for ST-elevation myocardial infarction (STEMI), including primary percutaneous coronary intervention (PCI) and guideline-directed medical therapy, according to institutional protocols. No placebo is administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older of either gender
- Diagnosis of STEMI
- Undergoing primary PCI
Key exclusion criteria (9 listed)
- Cardiogenic shock
- Severe hypotension (SBP <90 mmHg)
- Bradycardia with HR < 50 bpm without pacemaker
- Known hypersensitivity to adenosine
- Severe asthma or COPD with bronchospasm
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 |
|---|---|---|
| AdenosineProphylactic administration of 200 micrograms of intracoronary adenosine immediately before each balloon inflation or stent deployment during primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI). Adenosine is administered rapidly, within less than 30 seconds before each inflation, according to the study protocol. No additional vasodilator agents are used as part of this prophylactic protocol. The intervention is intended to reduce coronary slow-flow/no-reflow and improve post-PCI myocardial perfusion. | Drug | Experimental |
| Standard Treatment onlyPlacebo administered according to the study protocol alongside standard treatment for patients undergoing primary PCI for STEMI in control group | Other | Control |
Primary outcome
Incidence of Slow-Flow or No-Reflow After PPCI
Time frame: During the primary PCI procedure, immediately after completion of PCI (Day 1)
The proportion of participants with slow-flow or no-reflow on final post-PCI angiography, assessed using the Thrombolysis in Myocardial Infarction (TIMI) flow grade. Slow-flow/no-reflow is defined as final TIMI flow grade 0, 1, or 2 in the treated infarct-related artery, in the absence of a mechanical cause of impaired coronary flow.
6 secondary outcomes
Final TIMI Flow Grade
Time frame: During the primary PCI procedure, immediately after completion of PCI (Day 1)
Myocardial Blush Grade After Primary PCI
Time frame: During the primary PCI procedure, immediately after completion of PCI (Day 1)
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: At the time of Hospital Discharge (upto 10 Days) and at 30 days after PCI.
Safety of Prophylactic High-Dose Intracoronary Adenosine
Time frame: During the primary PCI procedure, immediately after completion of PCI (Day 1) & at time of Hospital Discharge (upto 10 Days) and at 30 days after PCI.
Left Ventricular Ejection Fraction at Discharge and 30 Days
Time frame: At the time of Hospital Discharge (upto 10 Days) and at 30 days after PCI.
Six-Minute Walk Distance at 30 Days
Time frame: 30 days after PCI.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available, including demographic characteristics, baseline clinical features, procedural and angiographic data (including TIMI flow grade and myocardial blush grade), study intervention allocation, adverse events, major adverse cardiovascular events, left ventricular ejection fraction, and six-minute walk test results, where collected. Data will be shared without direct personal identifiers and subject to applicable ethical, institutional, and data-protection requirements.
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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.
Muzaffar Ali Zahidi, MBBS,FCPS Med,FCPS Cardiology principal investigator
Punjab Institute of Cardiology Lahore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenosine and Standard Treatment only in people with ST-Elevation Myocardial Infarction (STEMI), run by Prof Muzaffar Ali Zahidi at 2 sites in Pakistan.
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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muzaffar Ali Zahidi, MBBS,FCPS Med,FCPS Cardiology (+923004358267, muzcardio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Slow-Flow or No-Reflow After PPCI (time frame: During the primary PCI procedure, immediately after completion of PCI (Day 1)). 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 27 Oct 2026.