- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04699110
Adrenaline for the Treatment of No-Reflow in Normotensive Patients
May 20, 2021 updated by: Kamran Ahmed Khan, National Institute of Cardiovascular Diseases, Karachi
Efficacy of Intracoronary Adrenaline and Its Comparison With Intracoronary Adenosine in the Treatment of No-Reflow in Normotensive Patients With Acute Coronary Syndrome
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
201
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- National Institute of Cardiovascular Diseases
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
Patients receiving intracoronary adrenaline
|
Treatment group will receive adrenaline (100 to 400 mcg) for the treatment of No-reflow
|
Active Comparator: Control group
Patients receiving intracoronary adenosine
|
Control group will receive adenosine (100 to 400 mcg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time Frame: Immediately after administration of drug
|
Immediately after administration of drug
|
Reduction in TIMI frame count
Time Frame: Immediately after administration of drug
|
Immediately after administration of drug
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The major adverse cardiovascular events
Time Frame: During hospital stay and at 30-day follow-up
|
During hospital stay and at 30-day follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
January 5, 2021
First Submitted That Met QC Criteria
January 5, 2021
First Posted (Actual)
January 7, 2021
Study Record Updates
Last Update Posted (Actual)
May 21, 2021
Last Update Submitted That Met QC Criteria
May 20, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Syndrome
- Acute Coronary Syndrome
- No-Reflow Phenomenon
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Purinergic Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Mydriatics
- Adenosine
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- ERC-76/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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