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Adrenaline for the Treatment of No-Reflow in Normotensive Patients

Efficacy of Intracoronary Adrenaline and Its Comparison With Intracoronary Adenosine in the Treatment of No-Reflow in Normotensive Patients With Acute Coronary Syndrome

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04699110
Enrollment
201
Registered
2021-01-07
Start date
2021-01-01
Completion date
2021-04-30
Last updated
2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, No-Reflow Phenomenon, Normotensive

Brief summary

No-reflow is defined as the lack of myocardial perfusion despite opening of the epicardial coronary vessels in the setting of percutaneous coronary intervention (PCI). It has been demonstrated that either impaired flow or the absence of flow is associated with an increased rate of mortality. Among available treatment options, intracoronary adenosine is widely used in clinical practice, moreover, adrenaline is a safe alternative for the cases where use of adenosine is limited due to presence of hypotension or bradycardia. Nonetheless, evidence from retrospective and observational studies suggest that intracoronary adrenaline is well tolerated and may exert encouraging effects in prompt recovery of flow in these patients. However, very limited data are available on efficacy of intracoronary (IC) adrenaline in normotensive patients. Therefore, this study is planned to study the hypothesis that; intracoronary adrenaline is safe and has significantly higher efficacy as compared to adenosine for the treatment of no-reflow in normotensive patients with acute coronary syndrome.

Interventions

DRUGAdrenaline

Treatment group will receive adrenaline (100 to 400 mcg) for the treatment of No-reflow

DRUGAdenosine

Control group will receive adenosine (100 to 400 mcg)

Sponsors

National Institute of Cardiovascular Diseases, Pakistan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients with acute coronary syndrome who developed No-reflow during PCI. * Patients with systolic blood pressure of \> 100 mmHg.

Exclusion criteria

* Hypotensive patients * Patients with Valvular or congenital heart disease. * Patients with Atypical chest pain * Patients with Cardiomyopathy * Patients with Pericarditis * Patients with Myocarditis * Patients refused to give consent

Design outcomes

Primary

MeasureTime frame
Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow gradeImmediately after administration of drug
Reduction in TIMI frame countImmediately after administration of drug

Secondary

MeasureTime frame
The major adverse cardiovascular eventsDuring hospital stay and at 30-day follow-up

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026