Back to resultsAdrenaline for the Treatment of No-Reflow in Normotensive Patients
Primary Purpose
Acute Coronary Syndrome, No-Reflow Phenomenon, Normotensive
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Adrenaline
Adenosine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome
Eligibility Criteria
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
Sites / Locations
- National Institute of Cardiovascular Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group
Control group
Arm Description
Patients receiving intracoronary adrenaline
Patients receiving intracoronary adenosine
Outcomes
Primary Outcome Measures
Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade
Reduction in TIMI frame count
Secondary Outcome Measures
The major adverse cardiovascular events
Full Information
NCT ID
NCT04699110
First Posted
January 5, 2021
Last Updated
May 20, 2021
Sponsor
National Institute of Cardiovascular Diseases, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT04699110
Brief Title
Adrenaline for the Treatment of No-Reflow in Normotensive Patients
Official Title
Efficacy of Intracoronary Adrenaline and Its Comparison With Intracoronary Adenosine in the Treatment of No-Reflow in Normotensive Patients With Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Cardiovascular Diseases, Pakistan
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, No-Reflow Phenomenon, Normotensive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Patients receiving intracoronary adrenaline
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients receiving intracoronary adenosine
Intervention Type
Drug
Intervention Name(s)
Adrenaline
Intervention Description
Treatment group will receive adrenaline (100 to 400 mcg) for the treatment of No-reflow
Intervention Type
Drug
Intervention Name(s)
Adenosine
Intervention Description
Control group will receive adenosine (100 to 400 mcg)
Primary Outcome Measure Information:
Title
Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time Frame
Immediately after administration of drug
Title
Reduction in TIMI frame count
Time Frame
Immediately after administration of drug
Secondary Outcome Measure Information:
Title
The major adverse cardiovascular events
Time Frame
During hospital stay and at 30-day follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Institute of Cardiovascular Diseases
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35000456
Citation
Khan KA, Qamar N, Saghir T, Sial JA, Kumar D, Kumar R, Qayyum D, Yasin U, Jalbani J, Karim M. Comparison of Intracoronary Epinephrine and Adenosine for No-Reflow in Normotensive Patients With Acute Coronary Syndrome (COAR Trial). Circ Cardiovasc Interv. 2022 Feb;15(2):e011408. doi: 10.1161/CIRCINTERVENTIONS.121.011408. Epub 2022 Jan 10.
Results Reference
derived
Learn more about this trial
Adrenaline for the Treatment of No-Reflow in Normotensive Patients
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