Characterization of Slow Coronary Flow | NCT02025101

Studies
Characterization of Slow Coronary Flow

NCT02025101

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Dec 31, 2013Estimated

Enrollment

90Estimated

Phase

Not provided

Conditions

Cardiovascular Abnormalities
Vascular Diseases

Interventions

Not provided

Countries

Israel

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

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jul 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Dec 29, 2013

First Submission Date that Met QC Criteria

Dec 29, 2013

First Posted Date

Dec 31, 2013Estimated

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

Dec 29, 2013

Last Update Posted Date

Dec 31, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Description of the phenomena "Slow Coronary Flow" (SCF), according to the data that has been collected from patients hospitalized with specific criteria. Clinical follow-up of these patients to determine whether they suffered from any cardial or psychological disorders that might be a result of SCF.

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

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

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Slow Coronary Flow		Patients who were hospitalized with anginal pain and with laboratory markers or pathological ECG for ischemia.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collection of characteristics of slow coronary flow from approximately 90 patient records	Characteristics of slow coronary flow will be collected from approximately 90 patient medical records and will analyzed to find the common variables. This analysis will show whether there is any statistical significance to these characteristics.	Six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

anginal pain
laboratory markers
pathological ECG for ischemia

Exclusion Criteria:

obstructed coronary artery during catheterization
very narrow coronary artery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who were hospitalized with anginal pain

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meni Amran, B.Sc.	Contact	972-505-679225		meni.amran@gmail.com

Overall Officials

Name	Affiliation	Role
Aaron Frimerman, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D018376	Cardiovascular Abnormalities
D014652	Vascular Diseases

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided