Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT01031095
Brief Summary:
The hypothesis:
Low dose intracoronary unfractionated heparin is as effective and safe as standard dose intravenous unfractionated heparin on patients with elective percutaneous coronary intervention.
Detailed Description:
Aim:
Primary objective:To evaluate the efficiency and safety of low dose intracoronary unfractioned heparin (UFH) on elective percutaneous coronary intervention (PCI).
Secondary objective:
* To evaluate the effect of low dose intracoronary UFH on myocardial ischemia after PCI.
* To evaluate the effect of low dose intracoronary UFH on bleeding complications after PCI.
* To evaluate the cost-effectivity of low dose intracoronary UFH on elective PCI
Study central:
* Bursa Postgraduate Hospital, Cardiology Clinic
Study population:
* we planned to enrol 200 patients.
* Patients will randomise in two groups (control group:100 patients, study group:100 patients)
Study works:-Write case report form for all patients
* Control for inclusion criteria
* Demographic data (age, gender)
* Height, weight, BMI and glomerular filtration rate (GFR)
* Risk factors
* laboratory data (biochemical and hematologic)
* Medication history
* Echocardiographic data
* Angiographic data
* Procedure time
* PCI data(vessel diameter, stent diameter, lesion and stent length, performed percutaneous transluminal coronary angioplasty (PTCA) or not, etc)
* Before and after procedure (activated clotting time) ACT value
* Before and after procedure troponin I (TnI) and Creatine kinase MB (CKMB) levels
* Note complication (MACE, bleeding, hematoma etc)
* Note femoral compression time.
4 weeks later note the first control data.
Six months later note the second control data.
Study:
NCT01031095
Study Brief:
Protocol Section:
NCT01031095