- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03488407
Evaluation of Feasibility of Radial Access for Primary Angioplasty and to Assess it in High Risk Subgroups
A Prospective Study to Evaluate Feasibility of Routine Use of Radial Access for Primary Angioplasty and to Assess it in Subgroups With Unfavorable Characteristics
Primary percutaneous coronary intervention is the preferred treatment for patients with ST-segment acute coronary syndrome. The radial access is an established approach, associated with a reduction in vascular access related complications after primary percutaneous coronary interventions. The purpose of this study is to examine the baseline characteristics, risk factors, procedural parameters and complications in patients with STEMI taken for primary angioplasty by radial access.
Data of all patients with acute STEMI with primary PCI through radial access is to be evaluated for baseline characteristics and procedural parameters and complications. Patients in the prospective study are followed up till discharge and any in-hospital complication noted.
This was a prospective, observational and descriptive study. Three hundred fifteen consecutive patients with an ST-segment elevation acute myocardial infarction (STEMI) treated with primary angioplasty by radial access, admitted between March 2016 and Feb 2017 were analyzed for their baseline characteristics, risk factors, and procedural parameters, complications and outcomes. High risk sub-groups analysis was also done. High risk groups includes patients with age >75yrs, cardiogenic shock, severe LV systolic dysfunction, acute left ventricular failure, high degree AV block, right ventricular infarction and low BMI. The study is conducted among patients with acute STEMI, considered for primary PCI through radial artery access at operator discretion.
This study analyzed the baseline characteristics of patients which includes clinical history, clinical examination, ECG, 2D ECHO, coronary angiogram to evaluate cardiovascular risk factors.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- All patients presenting with STEMI and being considered for primary PCI through radial access between March 2016 and Feb 2017.
Exclusion Criteria:
- Patients with ACS other than STEMI
- All primary PCI in STEMI through femoral access.
- All radial elective PCI.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of radial angioplasty success in whole cohort.
Tidsramme: one year
|
Angioplasty success rate (by TIMI flow grade)
|
one year
|
|
Evaluation of in-hospital complication.
Tidsramme: One year
|
Rate of local complications
|
One year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
High risk v/s non-high risk subgroup analysis
Tidsramme: one year
|
Non- inferiority of radial angioplasty for high risk group were assessed.
|
one year
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Rajesh Sharma, MD, Jubilee Mission Medical College & Research Institute
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2/16/IEC/JMMC&RI
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Primær angioplastik
-
Cairo UniversityIkke rekrutterer endnuCarious Primary | Carious anteriorsEgypten
-
Institut National de la Santé Et de la Recherche...Assistance Publique - Hôpitaux de ParisAfsluttetExcitabilitet af diaphragmatic Primary Motor CortexFrankrig
-
National Cancer Institute (NCI)Ikke rekrutterer endnuRecidiverende platinfølsomt tuba fallopii højgradigt serøst adenokarcinom | Recidiverende Platinfølsom Ovarie Højgradigt Serøs Adenokarcinom | Recurrent Platinum-Sensitive Primary Peritoneal High Grade Serous Adenocarcinoma | Recurrent Platinum-Sensitive Endometrioid Adenokarcinom i Æggelederen og andre forhold
-
OCHIN, Inc.University of FloridaUkendtAkutafdelingens udnyttelse | Primary Care Quality Metrics | Børnebesøg i de første 15 måneder af livet NQF 1392 | Diabetes mellitus NQF 0059 | Screening af kolorektal cancer NQF 0034 | Alkohol- og stofscreening