Coagulation Profile in Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention (GlobalACT)

April 13, 2022 updated by: Centre of Postgraduate Medical Education

Coagulation Profile in Patients Undergoing Coronary Intervention Measured With Activated Clotting Time, Global Thrombosis Test and Platelet Inhibition VerifyNow P2Y12 Test

The activated clotting time (ACT), global thrombosis test (GTT-3), platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI).

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The activated clotting time (ACT), global thrombosis test (GTT-3) and platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI) - 20 smoking and 20 non-smoking.The measurements will take place: before coronary angiography (CA), 10 minutes after unfractionated heparin (HNF), 2h after CA, 6h after CA, 30 days after CA

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bogumił Ramotowski, MD, PhD
  • Phone Number: +48604355784
  • Email: bram@onet.pl

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

40 patients, 20 smoking at least 10 cigarettes a day, 20 patients non-smoking (<1 cigarette in last 30 days)

Description

Inclusion Criteria:

  • patients scheduled do CA >18 years old

Exclusion Criteria:

  • pregnancy
  • previous treatment with P2Y12 inhibitors, novel oral anticoagulants (NOAC) or warfarin acenocoumarol in last 24 hours

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Non-smoking
Non-smoking patients undergoing coronary angiography or percutaneous coronary intervention
Smoking
Smoking patients undergoing coronary angiography or percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACT change
Time Frame: Baseline ACT , 10 minutes ACT, 2 hours ACT, 6 hours ACT, 30 days ACT
Activated Clotting Time
Baseline ACT , 10 minutes ACT, 2 hours ACT, 6 hours ACT, 30 days ACT
GTT-3 change
Time Frame: Baseline GTT-3, 10 minutes GTT-3, 2 hours GTT-3, 6 hours GTT-3, 30 days ACT
Global Thrombosis Test
Baseline GTT-3, 10 minutes GTT-3, 2 hours GTT-3, 6 hours GTT-3, 30 days ACT
VerifyNow change
Time Frame: Baseline VerifyNow, 10 minutes VerifyNow, 2 hours VerifyNow, 6 hours VerifyNow, 30 days ACT
Platelet inhibition P2Y12 test
Baseline VerifyNow, 10 minutes VerifyNow, 2 hours VerifyNow, 6 hours VerifyNow, 30 days ACT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre of Postgraduate Medical Education

Investigators

  • Principal Investigator: Bogumił Ramotowski, Centre of Postgraduate Medical Education

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 (Anticipated)

April 30, 2022

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

September 24, 2021

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69/VII/Budaj/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Smoking

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe