Surviving a Decade or More After Coronary Revascularization in a Middle Eastern Population (DECADE1+ME)

May 24, 2023 updated by: Ayman J Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group

Evolution of Risk Factors and Revascularization Among >1 Decade Survivors After Coronary Revascularization in the Middle East

The study will look at the cardiovascular risk factors as they arise, as well at the need for further revascularization after at least 10 years of coronary revascularization in Middle Eastern patients.

The PI will overlook the whole process. Dr Ahmad Tamari, the assistant to the PI will asses this whole process of data collection, management and manuscript drafting.

Study Overview

Detailed Description

Middle Eastern patients aged 18 years or above presenting to cardiology service at one tertiary care center who had coronary revascularization (stent or coronary bypass surgery, i.e., index procedure) at least 10 years back, will interviewed to determine:

  1. Evolution of cardiovascular risk factors in the period from index procedure to time of interview. These risk factors include; hypertension, diabetes, smoking, dyslipidemia and obesity.
  2. Need for further arterial revascularization from the index procedure to time of interview.

    These arterial revascularization procedures include A. Coronary: stent and/or bypass surgery B. Carotid endarterectomy. C. peripheral arterial revascularization D. Renal artery stent.

  3. Medications used at the time if interview with special emphases on the guideline-recommended medications including antiplatelet agents, beta blockers, statins and renin angiotensin blockers.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amman, Jordan
        • Istishari Hospital
      • Amman, Jordan
        • Specialty Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All comers who had undergone coronary stent or bypass surgery 10 years or more prior to interview. These patients will be asked about the appearance of new cardiovascular risk factors during this period and whether they had undergone further operations or procedures to the coronary arteries, carotid arteries, lower limb arteries ir renal arteries.

Description

Inclusion Criteria:

  1. Age 18 years or older
  2. Coronary stent or bypass 10 years ago or more.
  3. Dependable mental status to recall events.

Exclusion Criteria:

  1. Non coronary operations
  2. Inability to recall evnets

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors
Time Frame: Since index procedure to time of interview at least 10 years later
Appearance of diabetes, hypertension, smoking, dyslipidemia or obesity since index procedure
Since index procedure to time of interview at least 10 years later
Arterial revascularizations
Time Frame: Since index procedure to time of interview at least 10 years later
Undergoing further coronary stent or surgery, carotid stent or surgery, lower limbs stent or surgery, and renal artery stent.
Since index procedure to time of interview at least 10 years later

Collaborators and Investigators

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

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 (Actual)

June 1, 2018

Primary Completion (Actual)

June 10, 2019

Study Completion (Actual)

June 10, 2019

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DecadeOrMoreSurvivors01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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