DNA Repair in Patients With Stable Angina.

NCT ID: NCT04453267

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-05

Study Completion Date

2024-08-01

Brief Summary

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Markers of DNA damage and repair are present in both atherosclerotic plaques and peripheral blood mononuclear cells of patients with coronary artery disease. A positive correlation has been observed between the level of DNA damage and the severity of atherosclerotic lesions, as well as atherogenic risk factors such as smoking, hypertension and hyperlipidaemia. A number of in-vitro studies have implicated defective DNA repair in the development and progression of atherosclerotic lesions. In mouse models of atherosclerosis, the DNA repair signalling cascade has been shown to be amenable to pharmacological intervention and overexpression of specific repair proteins attenuate the development of atherosclerotic plaques. However, data regarding the role of DNA repair in the pathogenesis of atherosclerosis in humans are lacking. We have preliminary data indicating reduced DNA repair activity in patients with stable angina. This study will determine the molecular basis and the biological consequences of this observation.

Detailed Description

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Conditions

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Coronary Artery Disease Coronary Arteriosclerosis DNA Damage DNA Repair Abnormality

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient Arm.

Consecutive patients undergoing elective percutaneous coronary intervention (PCI) or isolated coronary artery bypass grafting (CABG) for symptomatic stable angina (SA) despite optimal medical therapy at the University Hospital Southampton NHS Foundation Trust will be prospectively enrolled (n=86).

No interventions administered. 40ml of whole blood in EDTA vials to be taken for cellular separation and analysis.

No interventions assigned to this group

Age and gender matched controls

Age and gender-matched patients being investigated for chest pain with unobstructed coronary arteries, defined as coronary stenosis ≤ 30% in any major epicardial vessel on CT or invasive coronary angiography, will also be recruited as controls (n=86).

40ml of whole blood in EDTA vials to be taken for cellular separation and analysis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Ability to provide written informed consent

Exclusion Criteria

* Age ≥ 80 years
* Inability to provide written informed consent
* Presentation with an acute coronary syndrome
* Severe valvular heart disease
* Hypertrophic cardiomyopathy
* Left ventricular ejection fraction ≤ 35%
* Prior coronary revascularisation (surgical or percutaneous)
* Diabetes Mellitus
* Clinical evidence of peripheral vascular disease
* Prior history of cerebrovascular disease
* Malignancy
* Active inflammatory disorders (e.g. rheumatoid arthritis/connective tissue disorder)
* Renal impairment eGFR \<60ml/min/1.73m2
* Anaemia (Hb \<100g/dL)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Mahmoudi, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation Trust

Locations

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University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Thomas R Gilpin, MBBCh

Role: CONTACT

0044 (0)2380777222 ext. 3912

Zoe Nicholas, BSc

Role: CONTACT

0044 (0)2380777222 ext. 8538

Facility Contacts

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Michael Mahmoudi, MD,PhD

Role: primary

0044 (0)23801208538 ext. 8538

Other Identifiers

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CAR0566

Identifier Type: -

Identifier Source: org_study_id

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