The Diastolic Pressure Gradient for Patients With Acute C... | NCT01671631

Studies
The Diastolic Pressure Gradient for Patients With Acute Coronary Syndrome: Evaluation of Non Culprit Lesions

NCT01671631

Sponsor

University Magna Graecia

Status

Unknown status

Last Update Posted

Aug 23, 2012Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Functional Evaluation of Non Culprit Lesions in ACS Patients

Interventions

Measurement of intracoronary pressure

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 20, 2012

First Submission Date that Met QC Criteria

Aug 22, 2012

First Posted Date

Aug 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2012

Last Update Posted Date

Aug 23, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration is currently required for functional evaluation of stenosis severity using the fractional flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the instantaneous wave-free ratio (iFR), was recently introduced.

Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow reserve (FFR) in ACS patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute Coronary Syndrome		Patients with Acute Coronary Syndrome and multivessel coronary artery disease undergoing functional evaluation of non-culprit lesions.	Other: Measurement of intracoronary pressure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measurement of intracoronary pressure	Other		Acute Coronary Syndrome

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 40 to 80 years
recent Acute Coronary Syndrome
indication for coronary angiography
presence of at least one non-culprit lesion requiring functional evaluation with fractional flow reserve (FFR):

Exclusion Criteria:

Haemodynamically significant valvular disease
controindication for Adenosin administration
previous CABG on the index vessel

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Acute Coronary Syndrome and multivessel coronary artery disease.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ciro Indolfi, Prof	Contact	+3909613647067		clinicaltrials-cardioumg@email.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiologia Interventistica UMG	Recruiting	Catanzaro	Calabria	88100	Italy

References Module

Citations

Not provided

Label	URL
Web site, Division of Cardiology at Magna graecia University	View source
Web site, Dipartimento di Scienze Mediche e Chirurgiche, Magna Graecia University	View source