Adrenaline for the Treatment of No-Reflow in Normotensive Patients

NCT ID: NCT04699110

Last Updated: 2021-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Coronary Syndrome No-Reflow Phenomenon Normotensive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

Patients receiving intracoronary adrenaline

Group Type EXPERIMENTAL

Adrenaline

Intervention Type DRUG

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

Control group

Patients receiving intracoronary adenosine

Group Type ACTIVE_COMPARATOR

Adenosine

Intervention Type DRUG

Control group will receive adenosine (100 to 400 mcg)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adrenaline

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

Intervention Type DRUG

Adenosine

Control group will receive adenosine (100 to 400 mcg)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Cardiovascular Diseases, Pakistan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kamran Ahmed Khan

Assistant Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institute of Cardiovascular Diseases

Karachi, Sindh, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35000456 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ERC-76/2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Regadenoson and Adenosine
NCT01809743 COMPLETED PHASE3
Beta-Blocker Heart Attack Trial (BHAT)
NCT00000492 COMPLETED PHASE3