Coronary Artery DiseaseNCT05210972
Coronary Artery Disease Severity in Newly Diagnosed Dysglycemia
An observational study of Coronary Artery Disease and Dysglycemia, run by Saud Al Babtain Cardiac Center at 1 site in Saudi Arabia.
Trial summary
This cohort study will measure how severe is the coronary artery disease (CAD), at time of CAD diagnosis, clinically and angiographically in the different cohorts of newly diagnosed diabetes and prediabetes versus normal glycemia patients in the study center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Dysglycemia
- What is being tested?
- Cardiac catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jul 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A single center cohort study, where all comers, adult patients without prior diagnosis of DM, who are admitted with a first-time diagnosis of CAD, as confirmed by invasive coronary angiography, either elective or as emergency, will be eligible. The study will prospectively enroll consecutives and contemporary cases for each group of diabetes, pre-diabetes and normal glycemia.
Who may be able to join
- All adult patients with consents.
- First time diagnosis of CAD and no prior diagnosis of diabetes milletus (DM), or prediabetes.
- Coronary artery disease confirmed by invasive coronary angiography.
Who cannot join
- Patients with known significant anemia, increased hemoglobin turnover, active hemoglobin drops or on erythropoietin therapy.
- Pregnant and post-partum patients (up to 3 months post-delivery).
- Patients with severe chronic renal failure (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.72 m2).
- Patients on any medications with glucose lowering effects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Severity of Newly Diagnosed Coronary Artery Disease in Patients With Newly Diagnosed Diabetes and Pre-diabetes: A Cohort Study in a Cardiac Center in Saudi Arabia
This cohort study will measure how severe is the coronary artery disease (CAD), at time of CAD diagnosis, clinically and angiographically in the different cohorts of newly diagnosed diabetes and prediabetes versus normal glycemia patients in the study center.
- Conditions
- Coronary Artery Disease, Dysglycemia
- Being tested
- Cardiac catheterization
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac catheterizationRadiation
All the study population will be exposed to diagnostic coronary angiography and invasive coronary intervention as per standard guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes | Patients with level of HbA1c ≥ 6.5%, or Fasting blood glucose (FBG) ≥126 mg/dL, or a random plasma glucose (RBG) ≥ 200 mg/dL in a patient with classic symptoms of hyperglycemia.
In the absence of unequivocal hyperglycemia, diagnosis will be based on two abnormal test results, for FBG or RBG and HbA1c, from the same sample or in two separate test samples. Receives: Radiation: Cardiac catheterization | |
| Prediabetes | HbA1c 5.7-6.4% or FBG 110 mg/dL to 125 mg/dL The diagnosis will be based on two abnormal test results, for FBG or RBG and HbA1c, from the same sample or in two separate test samples. Receives: Radiation: Cardiac catheterization | |
| Normal glycemia | HbA1c <5.7% and FBG 110 mg/dL Receives: Radiation: Cardiac catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery disease severity
To measure how severe is the CAD, at time of CAD diagnosis, clinically and angiographically in the different cohorts of newly diagnosed diabetes and prediabetes versus normal glycemia patients.
Measured: 1 day (During the hospital admission)
Secondary outcomes (1)
Correlation of HbA1c to CAD severity
To correlate the level of HbA1c to the clinical and angiographic severity of CAD in the study populations
Measured: 1 day (During the hospital admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jul 2021
- Primary completion30 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saud Al Babtain Cardiac Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210972
- Sponsor's protocol ID
- SBCC-IRB-2021-06
- Status last verified
- Oct 2022
- First submitted
- 12 Jan 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severity of Newly Diagnosed Coronary Artery Disease in Patients With Newly Diagnosed Diabetes and Pre-diabetes: A Cohort Study in a Cardiac Center in Saudi Arabia
- ClinicalTrials.gov ID
- NCT05210972
- Acronym / sponsor ID
- SBCC-IRB-2021-06
- Conditions
- Coronary Artery Disease, Dysglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Saud Al Babtain Cardiac CenterOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cohort study will measure how severe is the coronary artery disease (CAD), at time of CAD diagnosis, clinically and angiographically in the different cohorts of newly diagnosed diabetes and prediabetes versus normal glycemia patients in the study center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | Radiation: Cardiac catheterizationPatients with level of HbA1c ≥ 6.5%, or Fasting blood glucose (FBG) ≥126 mg/dL, or a random plasma glucose (RBG) ≥ 200 mg/dL in a patient with classic symptoms of hyperglycemia. In the absence of unequivocal hyperglycemia, diagnosis will be based on two abnormal test results, for FBG or RBG and HbA1c, from the same sample or in two separate test samples. |
| Prediabetes | – | Radiation: Cardiac catheterizationHbA1c 5.7-6.4% or FBG 110 mg/dL to 125 mg/dL The diagnosis will be based on two abnormal test results, for FBG or RBG and HbA1c, from the same sample or in two separate test samples. |
| Normal glycemia | – | Radiation: Cardiac catheterizationHbA1c <5.7% and FBG 110 mg/dL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A single center cohort study, where all comers, adult patients without prior diagnosis of DM, who are admitted with a first-time diagnosis of CAD, as confirmed by invasive coronary angiography, either elective or as emergency, will be eligible. The study will prospectively enroll consecutives and contemporary cases for each group of diabetes, pre-diabetes and normal glycemia.
Key inclusion criteria (3 listed)
- All adult patients with consents.
- First time diagnosis of CAD and no prior diagnosis of diabetes milletus (DM), or prediabetes.
- Coronary artery disease confirmed by invasive coronary angiography.
Key exclusion criteria (4 listed)
- Patients with known significant anemia, increased hemoglobin turnover, active hemoglobin drops or on erythropoietin therapy.
- Pregnant and post-partum patients (up to 3 months post-delivery).
- Patients with severe chronic renal failure (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.72 m2).
- Patients on any medications with glucose lowering effects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac catheterizationAll the study population will be exposed to diagnostic coronary angiography and invasive coronary intervention as per standard guidelines. | Radiation | Diabetes, Normal glycemia, Prediabetes |
Primary outcome
Coronary artery disease severity
Time frame: 1 day (During the hospital admission)
To measure how severe is the CAD, at time of CAD diagnosis, clinically and angiographically in the different cohorts of newly diagnosed diabetes and prediabetes versus normal glycemia patients.
1 secondary outcome
Correlation of HbA1c to CAD severity
Time frame: 1 day (During the hospital admission)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Dysglycemia, run by Saud Al Babtain Cardiac Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery disease severity (time frame: 1 day (During the hospital admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.