Evaluation of Emotional Status and Coronary Flow Characteristics by TIMI Frame Count Method (STRAIN-TIMI)

July 10, 2016 updated by: Ertan YETKIN

Effects of Emotional Status on Coronary Flow in Patients Undergoing Coronary Angiography:Multicenter TIMI Frame Count Assessment Study (STRAIN-TIMI Study)

This study evaluates the effects of emotional status on coronary flow in patients undergoing elective coronary angiography. Patients whom undergoing elective coronary angiography will fulfill the Beck Anxiety Inventory, Beck Depression Inventory, State-Trait Anxiety Inventory, Hospital Anxiety and Depression Scale. State Anxiety Inventory will be fulfilled both before the intervention and after 1 hour the patients learned the results of the coronary angiography. The other scales will be performed after 1 hour the patients learned their results. Coronary flow will be assessed by TIMI (Thrombolysis In Myocardial Infarction) frame count method.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

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

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Ankara Numune Training and Research Hospital
        • Contact:
          • Mehmet Ileri, MD
        • Contact:
        • Principal Investigator:
          • Mehmet Ileri, MD
        • Sub-Investigator:
          • Hayriye Mihrimah Ozturk, MD
      • Ankara, Turkey
        • Active, not recruiting
        • Ankara Research and Training Hospital
      • Ankara, Turkey
        • Active, not recruiting
        • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
      • Malatya, Turkey
        • Recruiting
        • Private Gözde Hospital
        • Contact:
          • Izzet Tandogan, MD
        • Principal Investigator:
          • Izzet Tandogan, MD
      • Mersin, Turkey
        • Recruiting
        • Private Yenisehir Hospital
        • Contact:
        • Principal Investigator:
          • Ertan Yetkin, MD
    • Kecioren
      • Ankara, Kecioren, Turkey
        • Recruiting
        • Gülhane Military Medical Academy
        • Contact:
        • Principal Investigator:
          • Turgay Celik, MD

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients whom planned elective coronary angiography and accept to be included in the study as a participant

Exclusion Criteria:

  • < 18 years, history of prior coronary angiography, history of coronary artery revascularization, acute coronary syndrome patients, atrial fibrillation, heart failure, known systemic diseases

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: coronary artery ectasia
coronary angiography will be performed by transfemoral or transradial route.
Procedure: coronary angiography
Coronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken.
Active Comparator: obstructive coronary artery disease
coronary angiography will be performed by transfemoral or transradial route.
Procedure: coronary angiography
Coronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken.
Active Comparator: normal coronary anatomy
coronary angiography will be performed by transfemoral or transradial route.
Procedure: coronary angiography
Coronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken.
Active Comparator: slow coronary flow
coronary angiography will be performed by transfemoral or transradial route.
Procedure: coronary angiography
Coronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken.
Active Comparator: nonobstructive coronary artery disease
coronary angiography will be performed by transfemoral or transradial route.
Procedure: coronary angiography
Coronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TIMI frame count method analysis
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Ertan YETKIN

Collaborators

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Ankara City Hospital Bilkent
Abant Izzet Baysal University
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Private Yenisehir Hospital
Private Gozde Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

July 10, 2016

First Submitted That Met QC Criteria

July 10, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 10, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vasmol001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The results will be made available within 6 months of study completion

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.

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